Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-08 @ 11:43 AM
Study NCT ID:
NCT00355368
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2006-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Sponsor:
Organization:
Raw JSON
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Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Succinylcholine'}, {'id': 'OG001', 'title': 'Rocuronium'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during laryngoscopy and the first minute after completion of intubation', 'description': 'The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.\n\nUnits: measure on a scale', 'unitOfMeasure': 'score points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Failed First Intubation Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Succinylcholine'}, {'id': 'OG001', 'title': 'Rocuronium'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within the first 90 sec following the start of induction', 'description': 'defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Succinylcholine', 'description': '1mg/kg'}, {'id': 'FG001', 'title': 'Rocuronium', 'description': '0.6mg/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'cardiac arrest prior to intubation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Succinylcholine', 'description': '1mg/kg'}, {'id': 'BG001', 'title': 'Rocuronium', 'description': '0.6mg/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '16', 'groupId': 'BG000'}, {'value': '63', 'spread': '14', 'groupId': 'BG001'}, {'value': '61', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-10', 'studyFirstSubmitDate': '2006-07-20', 'resultsFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2006-07-20', 'lastUpdatePostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-10', 'studyFirstPostDateStruct': {'date': '2006-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Exhibiting Desaturation >5%', 'timeFrame': 'at any time between the start of the intubation sequence and 2min after the completion of intubation', 'description': 'decrease of \\>5% in oxygen saturation measured continuously using pulse oxymetry'}], 'secondaryOutcomes': [{'measure': 'Haemodynamic Sequelae of Intubation', 'timeFrame': 'between start of induction sequence and 5 min after completion of intubation', 'description': 'any new haemodynamic alteration requiring immediate intervention'}, {'measure': 'Time to Completion of Intubation', 'timeFrame': 'time interval between the injection of the induction agent and the first appearance of endtidal CO2', 'description': 'time interval between the injection of the induction agent and the first appearance of endtidal CO2'}, {'measure': 'Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.', 'timeFrame': 'during laryngoscopy and the first minute after completion of intubation', 'description': 'The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.\n\nUnits: measure on a scale'}, {'measure': 'Number of Participants With an Failed First Intubation Attempts', 'timeFrame': 'within the first 90 sec following the start of induction', 'description': 'defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intubation', 'intensive care', 'neuromuscular depolarizing agents', 'neuromuscular nondepolarizing agents', 'neuromuscular blocking agents'], 'conditions': ['Intubation']}, 'referencesModule': {'references': [{'pmid': '16243994', 'type': 'BACKGROUND', 'citation': 'Sluga M, Ummenhofer W, Studer W, Siegemund M, Marsch SC. Rocuronium versus succinylcholine for rapid sequence induction of anesthesia and endotracheal intubation: a prospective, randomized trial in emergent cases. Anesth Analg. 2005 Nov;101(5):1356-1361. doi: 10.1213/01.ANE.0000180196.58567.FE.'}, {'pmid': '21846380', 'type': 'DERIVED', 'citation': 'Marsch SC, Steiner L, Bucher E, Pargger H, Schumann M, Aebi T, Hunziker PR, Siegemund M. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial. Crit Care. 2011 Aug 16;15(4):R199. doi: 10.1186/cc10367.'}]}, 'descriptionModule': {'briefSummary': 'Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.', 'detailedDescription': 'Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.\n\nDesign: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).\n\nData: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for emergency intubation in intensive care\n* availability of qualified study physician\n\nExclusion Criteria:\n\n* contraindication against succinylcholine or rocuronium\n* indication for awake fibreoptic intubation'}, 'identificationModule': {'nctId': 'NCT00355368', 'briefTitle': 'Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care', 'orgStudyIdInfo': {'id': 'EK 145/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Succinylcholine', 'interventionNames': ['Drug: Succinylcholine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rocuronium', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Succinylcholine', 'type': 'DRUG', 'description': '1mg/kg iv', 'armGroupLabels': ['Succinylcholine']}, {'name': 'Rocuronium', 'type': 'DRUG', 'description': '0.6mg/kg iv', 'armGroupLabels': ['Rocuronium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Department of Medical Intensive Care; University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Martin Siegemund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgical Intensive Care, University of Basel'}, {'name': 'Stephan C Marsch, MD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Intensive Care, University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman of Medical ICU', 'investigatorFullName': 'Stephan Marsch', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}