Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-06 @ 3:29 PM
Study NCT ID:
NCT01441960
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2011-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013390', 'term': 'Succinylcholine'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D002794', 'term': 'Choline'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013386', 'term': 'Succinates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anozari@partners.org', 'phone': '978-318-3933', 'title': 'Ala Nozari', 'organization': 'Mass General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NMBA: Succinylcholine', 'description': 'No adverse events occurred during the study', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NMBA: Rocuronium', 'description': 'No adverse events occurred during the study', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Optimal Dose of Neuromuscular Blocking Agent During ECT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMBA: Sux', 'description': "Cross-over randomized controlled, assessor blinded clinical trial.\n\nSuccinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."}, {'id': 'OG001', 'title': 'NMBA- Rocuronium', 'description': "Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments."}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '0.94'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.46'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to six weeks following inclusion', 'description': "The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.", 'unitOfMeasure': 'mg.kg-1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compound Specific Differences in Time to Recovery From Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Succinylchline', 'description': 'Time to recovery after single bolus administered at the beginning of ECT therapy'}, {'id': 'OG001', 'title': 'Rocuronium', 'description': 'Time to recovery after single bolus administered at the beginning of ECT therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to six weeks following inclusion', 'description': 'The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences in Seizure Duration Between Compounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Succinylcholine', 'description': 'Duration of induced seizure after standard ECT'}, {'id': 'OG001', 'title': 'Rocuronium', 'description': 'Duration of induced seizure'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '14', 'groupId': 'OG000'}, {'value': '31', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to six weeks following inclusion', 'description': 'Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Succinylcholine First, Then Rocuronium', 'description': 'After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.\n\nBy identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.'}, {'id': 'FG001', 'title': 'Rocuronium First , Then Succinylcholine', 'description': 'After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.\n\nBy identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.'}], 'periods': [{'title': 'First Neuromuscular Blocking Agent:', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Technical error or incomplete ECT series', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Neuromuscular Blocking Agent', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '45 hospitalized patients aged 24-80 admitted for a series of ECT treatments at a frequency of 3/week were enrolled. 14 were excluded (1 received rocuronium in error, 1 received succinylcholine in error, 1 withdrew consent, 2 did not complete series of ECT, and in 9 twitch monitoring problems resulted in non-captured or disqualified data.', 'preAssignmentDetails': 'Patients were randomized to either succinylcholine or rocuronium during their first ECT. During each subsequent ECT ( 2 days apart) patients received a 10% higher (if insufficient paralysis) or lower dose (if sufficient or excessive paralysis) until the minimum effective dose was identified. Then the second NMBA was tested for subsequent ECTs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Succinylcholine and Rocuronium', 'description': 'All study participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2011-09-20', 'resultsFirstSubmitDate': '2015-04-09', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-01', 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal Dose of Neuromuscular Blocking Agent During ECT', 'timeFrame': 'Up to six weeks following inclusion', 'description': "The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study."}], 'secondaryOutcomes': [{'measure': 'Compound Specific Differences in Time to Recovery From Neuromuscular Blockade', 'timeFrame': 'Up to six weeks following inclusion', 'description': 'The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.'}, {'measure': 'Differences in Seizure Duration Between Compounds', 'timeFrame': 'Up to six weeks following inclusion', 'description': 'Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Succinylcholine', 'Rocuronium', 'ECT'], 'conditions': ['Neuromuscular Blockade', 'ECT']}, 'referencesModule': {'references': [{'pmid': '10078403', 'type': 'BACKGROUND', 'citation': 'Cheam EW, Critchley LA, Chui PT, Yap JC, Ha VW. Low dose mivacurium is less effective than succinylcholine in electroconvulsive therapy. Can J Anaesth. 1999 Jan;46(1):49-51. doi: 10.1007/BF03012514.'}, {'pmid': '19100931', 'type': 'BACKGROUND', 'citation': 'Turkkal DC, Gokmen N, Yildiz A, Iyilikci L, Gokel E, Sagduyu K, Gunerli A. A cross-over, post-electroconvulsive therapy comparison of clinical recovery from rocuronium versus succinylcholine. J Clin Anesth. 2008 Dec;20(8):589-93. doi: 10.1016/j.jclinane.2008.06.006.'}, {'pmid': '16142990', 'type': 'BACKGROUND', 'citation': 'Wagner KJ, Mollenberg O, Rentrop M, Werner C, Kochs EF. Guide to anaesthetic selection for electroconvulsive therapy. CNS Drugs. 2005;19(9):745-58. doi: 10.2165/00023210-200519090-00002.'}, {'pmid': '12378667', 'type': 'BACKGROUND', 'citation': 'Eikermann M, Hunkemoller I, Peine L, Armbruster W, Stegen B, Husing J, Peters J. Optimal rocuronium dose for intubation during inhalation induction with sevoflurane in children. Br J Anaesth. 2002 Aug;89(2):277-81. doi: 10.1093/bja/aef177.'}, {'pmid': '11498311', 'type': 'BACKGROUND', 'citation': 'Miguel RV, Soto R, Dyches P. A double-blind, randomized comparison of low-dose rocuronium and atracurium in a desflurane anesthetic. J Clin Anesth. 2001 Aug;13(5):325-9. doi: 10.1016/s0952-8180(01)00282-3.'}, {'pmid': '8712436', 'type': 'BACKGROUND', 'citation': 'Reynolds LM, Lau M, Brown R, Luks A, Fisher DM. Intramuscular rocuronium in infants and children. Dose-ranging and tracheal intubating conditions. Anesthesiology. 1996 Aug;85(2):231-9. doi: 10.1097/00000542-199608000-00002.'}]}, 'descriptionModule': {'briefSummary': 'Electroconvulsive therapy (ECT) is the transcutaneous application of small electrical stimuli to the brain to produce generalized seizures for the treatment of selected psychiatric disorders such as severe depression. The aim of ECT is to induce a therapeutic tonic seizure where the person loses consciousness and has convulsions. Patients need general anesthesia and neuromuscular blockade to treat pain and avoid excessive tonic clonic motor contraction that might be associated with compression fractures. Neuromuscular blocking drugs (NMBD) are, therefore, administered after induction of general anesthesia to induce neuromuscular blockade. Despite the importance of NMBDs to provide optimal conditions for ECT treatment, the optimal NMBD dose to achieve acceptable neuromuscular blockade without excessive or untoward effects has not previously been identified in any study and in a prospective randomized fashion. The aim of this study is, therefore, to identify the optimal NMBD dose of two commonly used neuromuscular blocking agents (succinylcholine and rocuronium) in order to optimize the muscle strength modulation during ECT that facilitates ECT with the minimal side effects.', 'detailedDescription': "Patients, who consent to participate in the study, will randomly receive either succinylcholine or rocuronium by utilizing the Dixon's up and down technique. For patient safety, the first dose of either agent will be defined by the anesthesiologist providing care, and subsequent doses will be incrementally increased or decreased by 10% based on the assessment of a psychiatrist blinded to dose, who uses a dichotomous scale to assess the quality of the ECT (acceptable and not acceptable). The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.\n\nAcceleromyography will be used for monitoring neuromuscular transmission. Following induction of general anesthesia, the TOF-Watch SX will be calibrated (mode 1, 50 mA), and train-of-four (TOF) stimulation (every 15 seconds) will be initiated and maintained until recovery of the T1 to 100% baseline. Non-invasive blood pressure, heart rate, peripheral oxygen saturation (SpO2), and time to recovery of spontaneous breathing will be measured during the procedure. In addition the investigators will measure stimulation parameters used to initiate ECT, as well as the duration of seizure as well as the entire procedure time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age 18-80) scheduled for ECT treatment at the MGH\n\nExclusion Criteria:\n\n* Contraindication to the use of neuromuscular blocking drugs (e.g. allergy, preexisting muscular disease, and history of malignant hyperthermia)\n* Malnutrition, general weakness\n* Neurological or neuromuscular disease, including paralysis\n* Liver disease with liver function test 2x greater than upper normal limit\n* Kidney disease with eGFR\\<60\n* Electrolyte abnormalities with values outside of the normal range\n* Pregnancy\n* Cardiac disease or abnormal EKG\n* Medications that affect seizure threshold or blood pressure response\n* Unwilling to participate in the study'}, 'identificationModule': {'nctId': 'NCT01441960', 'briefTitle': 'Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Optimal Control of Muscle Strength for Electroconvulsive Therapy: A Comparison of Succinylcholine Versus Rocuronium-induced Neuromuscular Blockade', 'orgStudyIdInfo': {'id': '2010P001154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Succinylcholine first, then Rocuronium', 'description': 'Cross-over randomized controlled, assessor blinded clinical trial.', 'interventionNames': ['Drug: Succinylcholine', 'Drug: Rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Rocuronium first, then succinylcholine', 'description': 'Cross-over randomized controlled, assessor blinded clinical trial.', 'interventionNames': ['Drug: Succinylcholine', 'Drug: Rocuronium']}], 'interventions': [{'name': 'Succinylcholine', 'type': 'DRUG', 'otherNames': ['Suxamethonium'], 'description': "Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.", 'armGroupLabels': ['Rocuronium first, then succinylcholine', 'Succinylcholine first, then Rocuronium']}, {'name': 'Rocuronium', 'type': 'DRUG', 'description': "Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.", 'armGroupLabels': ['Rocuronium first, then succinylcholine', 'Succinylcholine first, then Rocuronium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthias Eikermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Ala Nozari, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ala Nozari', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}