Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-22 @ 12:22 PM
Study NCT ID:
NCT02197403
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paradoxical excitement response', 'timeFrame': 'Every 5 minutes up to 120minutes after drug infusion', 'description': 'Paradoxical excitement responses (verbal/movement) 0, none : no excitement response\n\n1. mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining\n2. moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint\n3. severe : agitation and spontaneous movements with a need to restrain the patient'}], 'secondaryOutcomes': [{'measure': 'OAA/S', 'timeFrame': 'Every 5minutes up to 120minutes after drug infusion', 'description': "Observer''s Assessment of Alertness/Sedation Scale (OAA/S)\n\n1. :Does not respond to mild prodding or shaking\n2. :Responds only after mild prodding or shaking\n3. :Responds only after name is spoken loudly and/or repeatedly\n4. :Lethargic response to name spoken in normal tone\n5. :Responds readily to name spoken in normal tone\n\nGoal to sedation : 3"}, {'measure': 'Vital signs', 'timeFrame': 'During operation', 'description': 'Check blood pressure, heart rate, oxygen saturation, bispectral index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Sedation', 'Paradoxical excitement response', 'Alcohol drinkers'], 'conditions': ['Anesthesia, Spinal', 'Sedation, Conscious', 'Dexmedetomidine', 'Alcohol Drinking', 'Anesthesia, Epidural', 'Propofol']}, 'referencesModule': {'references': [{'pmid': '21903640', 'type': 'RESULT', 'citation': 'Jeong S, Lee HG, Kim WM, Jeong CW, Lee SH, Yoon MH, Choi JI. Increase of paradoxical excitement response during propofol-induced sedation in hazardous and harmful alcohol drinkers. Br J Anaesth. 2011 Dec;107(6):930-3. doi: 10.1093/bja/aer275. Epub 2011 Sep 7.'}, {'pmid': '23748199', 'type': 'RESULT', 'citation': 'Adams R, Brown GT, Davidson M, Fisher E, Mathisen J, Thomson G, Webster NR. Efficacy of dexmedetomidine compared with midazolam for sedation in adult intensive care patients: a systematic review. Br J Anaesth. 2013 Nov;111(5):703-10. doi: 10.1093/bja/aet194. Epub 2013 Jun 7.'}, {'pmid': '22436955', 'type': 'RESULT', 'citation': 'Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.'}, {'pmid': '19713256', 'type': 'RESULT', 'citation': 'Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.'}]}, 'descriptionModule': {'briefSummary': '1. Adequate sedation with classical sedative agents, propofol\n2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol drinkers\n3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol drinkers', 'detailedDescription': '1. Adequate sedation during surgery provide anxiolysis and comfort to patient. Insufficient sedation can\'t provide comfort to patient during surgery, otherwise excessive sedation can cause variable complications like respiratory depression or delayed awakening.\n2. Dexmedetomidine is a centrally acting α2 receptor agonist that is increasingly being used as a sedative for MAC and intensive care with mechanical ventilated patients because of its analgesic properties, "cooperative sedation," and lack of respiratory depression.\n3. Because of the different site of action between dexmedetomidine and propofol, we assumed that paradoxical excitement responses which appeared in heavy alcohol drinkers in midazolam or propofol-induced sedation might be less observed in dexmedetomidine-induced sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19\\~65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia\n\nExclusion Criteria:\n\n* History of taking anxiolytics, hypnotics, antiepileptic drugs\n* Abnormal liver function test (eg: Liver cirrhosis, elevated liver enzymes)\n* History of allergic reaction with dexmedetomidine or propofol\n* Contraindication with regional anesthesia\n* American society of anesthesiologist Physical status III or IV'}, 'identificationModule': {'nctId': 'NCT02197403', 'acronym': 'DEX', 'briefTitle': 'Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers', 'orgStudyIdInfo': {'id': 'an00543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alcohol drinker & dexmedetomidine', 'description': 'dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\\~1.0mcg/Kg infusion during surgery', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'alcohol drinker & propofol', 'description': 'Propofol (2% fresofol) 25\\~75mcg/kg/min continuous infusion', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-alcohol drinker & dexmedetomidine', 'description': 'dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\\~1.0mcg/Kg infusion during surgery', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-alcohol drinker & propofol', 'description': 'Propofol (2% fresofol) 25\\~75mcg/kg/min continuous infusion', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': '200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\\~1.0mcg/Kg infusion', 'armGroupLabels': ['Non-alcohol drinker & dexmedetomidine', 'alcohol drinker & dexmedetomidine']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Fresofol'], 'description': '25\\~75mcg/kg/min continuous infusion', 'armGroupLabels': ['Non-alcohol drinker & propofol', 'alcohol drinker & propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501-757', 'city': 'Hwasun', 'state': 'Jeollanamdo', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Changbeom Park, Master', 'role': 'CONTACT', 'email': 'cnuhpch@naver.com', 'phone': '82-61-379-7598'}, {'name': 'Hyunjung Lee, M.D, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeongil Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}], 'overallOfficials': [{'name': 'Hyunjung Lee, MD, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Jeongil Choi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-il Choi', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}