Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-01 @ 10:12 PM
Study NCT ID:
NCT01517932
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2012-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2012-01-22', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence agitation', 'timeFrame': 'during 0-3 postoperative hours', 'description': 'Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain at rest', 'timeFrame': 'At 1,3 postoperative hours', 'description': 'The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale（VAS）and prince-henry score'}, {'measure': 'dosage Dosage of analgesics', 'timeFrame': 'during 3 postoperative hours'}, {'measure': 'Recovery time', 'timeFrame': 'At the moment of the eyes opend when calling the names'}, {'measure': 'Postoperative sedation', 'timeFrame': 'at 0,1,3 postoperative hours', 'description': 'It was assessed by Ramsay Sedation Score(RSS)'}, {'measure': 'Extubation time', 'timeFrame': 'at the moment of extubation'}, {'measure': 'Breathing recovery time', 'timeFrame': 'when autonomous respiration recovered'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Restlessness', 'Pain']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.\n\nIn this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.', 'detailedDescription': 'Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II\n* undergoing selective thoracotomy\n* weight between 45 and 75kg\n* operation time 2-4 hours\n\nExclusion Criteria:\n\n* history of neurologic disease\n* history of chronic analgesics intake\n* history of allergic reactions to the experimental durgs\n* history of renal insufficiency\n* history of hepatic dysfunction\n* history of coagulation disorders\n* women in lactation\n* participating in other studies'}, 'identificationModule': {'nctId': 'NCT01517932', 'briefTitle': 'Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period', 'orgStudyIdInfo': {'id': 'TJMU-A-201106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-DEX', 'description': 'Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group-PLB', 'description': 'Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery', 'interventionNames': ['Drug: saline placebo']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': 'In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.\n\nAnaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.\n\nPatients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery', 'armGroupLabels': ['Group-DEX']}, {'name': 'saline placebo', 'type': 'DRUG', 'description': 'In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.\n\nAnaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.\n\nPatients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery', 'armGroupLabels': ['Group-PLB']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fang Luo, MD.PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fang Luo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}