Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-31 @ 10:44 PM
Study NCT ID:
NCT01438957
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer'}, 'certainAgreement': {'otherDetails': 'If an investigator publishes any results of this study, a pre-publication manuscript shall be provided the sponsor for review at least 60 days prior to the submission of the manuscript to the publisher.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasculitides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glossoptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '33.6'}, {'value': '45.8', 'groupId': 'OG002', 'lowerLimit': '25.6', 'upperLimit': '67.2'}, {'value': '68.0', 'groupId': 'OG003', 'lowerLimit': '46.5', 'upperLimit': '85.1'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '59.3', 'upperLimit': '93.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'groupDescription': 'Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.', 'statisticalMethod': 'Mantel-extension test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '1.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after the start of study drug, if the OAA/S score is 5.', 'unitOfMeasure': 'Number of dosing', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.019', 'spread': '0.933', 'groupId': 'OG000'}, {'value': '0.744', 'spread': '0.675', 'groupId': 'OG001'}, {'value': '0.373', 'spread': '0.459', 'groupId': 'OG002'}, {'value': '0.166', 'spread': '0.298', 'groupId': 'OG003'}, {'value': '0.096', 'spread': '0.231', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after the start of study drug, if the OAA/S score is 5.', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Time to First Rescue Administration of Propofol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '46.0'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '22.0'}, {'value': '24', 'comment': 'The estimate dose not reach the point of 50%.', 'groupId': 'OG002', 'lowerLimit': '21.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The estimate dose not reach the point of 50%.', 'groupId': 'OG003', 'lowerLimit': '61.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The estimate dose not reach the point of 50%.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEDIAN', 'timeFrame': 'During the study drug infusion period (≥15 minutes [Approximate])', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '77.2', 'upperLimit': '99.9'}, {'value': '91.3', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '98.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '85.8', 'upperLimit': '100.0'}, {'value': '96.0', 'groupId': 'OG003', 'lowerLimit': '79.6', 'upperLimit': '99.9'}, {'value': '96.0', 'groupId': 'OG004', 'lowerLimit': '79.6', 'upperLimit': '99.9'}]}]}], 'analyses': [{'pValue': '0.869', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'NUMBER', 'timeFrame': 'After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Number of Fentanyl Dosing Required During the Study Drug Administration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.897', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': 'During the study drug administration', 'unitOfMeasure': 'Number of dosing', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Dosage of Fentanyl Dosing Required During the Study Drug Administration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.068', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '0.085', 'spread': '0.317', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '0.018', 'spread': '0.088', 'groupId': 'OG003'}, {'value': '0.061', 'spread': '0.304', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.897', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': 'During the study drug administration', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '50.17', 'spread': '23.88', 'groupId': 'OG000'}, {'value': '58.15', 'spread': '20.71', 'groupId': 'OG001'}, {'value': '61.44', 'spread': '18.28', 'groupId': 'OG002'}, {'value': '70.07', 'spread': '21.08', 'groupId': 'OG003'}, {'value': '76.78', 'spread': '14.07', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}, {'pValue': '0.116', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '47.88', 'spread': '25.31', 'groupId': 'OG000'}, {'value': '56', 'spread': '19.87', 'groupId': 'OG001'}, {'value': '53.66', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '65.3', 'spread': '20.63', 'groupId': 'OG003'}, {'value': '62.25', 'spread': '23.14', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.088', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'comment': 'There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15', 'comment': 'There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '16.0'}, {'value': '15', 'comment': 'There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15', 'comment': 'There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.085', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value 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Low values indicated more ease of maintenance of sedation level.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}, {'type': 'SECONDARY', 'title': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'OG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'OG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.374', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the anesthesia type'}], 'paramType': 'MEAN', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'FG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'FG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'FG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'FG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '119', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose'}, {'id': 'BG001', 'title': 'Dexmedetomidine 0.067 mcg/kg', 'description': '0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'BG002', 'title': 'Dexmedetomidine 0.25 mcg/kg', 'description': '1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'BG003', 'title': 'Dexmedetomidine 0.5 mcg/kg', 'description': '3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'BG004', 'title': 'Dexmedetomidine 1.0 mcg/kg', 'description': '6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '86'}, {'value': '60.7', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '85'}, {'value': '63.8', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '86'}, {'value': '60.0', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '80'}, {'value': '59.3', 'groupId': 'BG004', 'lowerLimit': '26', 'upperLimit': '82'}, {'value': '62.4', 'groupId': 'BG005', 'lowerLimit': '26', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '119', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set\\<FAS\\>: FAS is defined as all patients who were administered with the study drugs.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2011-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2011-09-21', 'resultsFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2011-09-21', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-19', 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.", 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.'}], 'secondaryOutcomes': [{'measure': 'Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration', 'timeFrame': '15 minutes after the start of study drug, if the OAA/S score is 5.'}, {'measure': 'Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration', 'timeFrame': '15 minutes after the start of study drug, if the OAA/S score is 5.'}, {'measure': 'Time to First Rescue Administration of Propofol', 'timeFrame': 'During the study drug infusion period (≥15 minutes [Approximate])'}, {'measure': 'Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration', 'timeFrame': 'After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.'}, {'measure': 'Number of Fentanyl Dosing Required During the Study Drug Administration.', 'timeFrame': 'During the study drug administration'}, {'measure': 'Dosage of Fentanyl Dosing Required During the Study Drug Administration.', 'timeFrame': 'During the study drug administration'}, {'measure': 'Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion', 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.'}, {'measure': 'Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion', 'timeFrame': 'Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.'}, {'measure': 'Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion', 'timeFrame': 'Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.'}, {'measure': 'Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)', 'timeFrame': 'Within 24 hours after completion of the study drug administration', 'description': 'VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)', 'timeFrame': 'Within 24 hours after completion of the study drug administration', 'description': 'VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)', 'timeFrame': 'Within 24 hours after completion of the study drug administration', 'description': 'VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.'}, {'measure': "Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)", 'timeFrame': 'Within 24 hours after completion of the study drug administration', 'description': 'VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.'}, {'measure': 'Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")', 'timeFrame': 'Within 24 hours after completion of the study drug administration (as much as possible)', 'description': 'Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Sedation', 'Non-intubation', 'epidural anesthesia', 'spinal anesthesia'], 'conditions': ['Sedation']}, 'referencesModule': {'references': [{'pmid': '35221757', 'type': 'DERIVED', 'citation': 'Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.', 'detailedDescription': 'Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient has signed and dated the Informed Consent after the study had been fully explained.\n2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained.\n3. American Society for Anesthesiologists (ASA) I to III Class.\n4. Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.\n5. Patient undergoing a surgery requiring epidural or spinal anesthesia\n\nExclusion Criteria:\n\n1. Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.\n2. Patient with \\<92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.\n3. Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.\n4. Patient who require general anesthesia.\n5. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.\n6. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.\n7. Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.\n8. Patient whose heart rate is \\<60 bpm, systolic blood pressure is \\<90 mmHg by the physical examination prior to the study drug administration.\n9. Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.\n10. Patient who has experienced an increase in alanine transaminase (ALT) and / or aspartate aminotransferase (AST) more than double the upper normal limit within 2 months of the date of consent, or who has a history of liver insufficiency.\n11. Pregnant or lactating woman.\n12. In the Investigator's or subinvestigator's opinion, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data"}, 'identificationModule': {'nctId': 'NCT01438957', 'briefTitle': 'Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care', 'orgStudyIdInfo': {'id': 'DEX-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine 0.067 mcg/kg', 'description': 'Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine 0.25 mcg/kg', 'description': 'Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine 0.5 mcg/kg', 'description': 'Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine 1.0 mcg/kg', 'description': 'Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride']}], 'interventions': [{'name': 'Dexmedetomidine hydrochloride', 'type': 'DRUG', 'description': 'Dexmedetomidine 0.2 to 0.7 mcg/kg/hr', 'armGroupLabels': ['Dexmedetomidine 0.067 mcg/kg', 'Dexmedetomidine 0.25 mcg/kg', 'Dexmedetomidine 0.5 mcg/kg', 'Dexmedetomidine 1.0 mcg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Asahikawa Medical University Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Nangoku', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School Hospital'}, {'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Shinshul University Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Izumo', 'state': 'Shimane', 'country': 'Japan', 'facility': 'Shimane University Hospital', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'city': 'Yonago', 'state': 'Tottori', 'country': 'Japan', 'facility': 'Tottori University Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Japanese Red Cross Kyoto Daini Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 'University of Miyazaki Hospital', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Kitano Hospital, The Tazuke Kofukai Medical Research Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Medical University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Maruishi Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}