Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-03-27 @ 4:06 AM
Study NCT ID:
NCT04581395
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2020-09-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Pretreatment With Roc on Succinylcholine Myalgias
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D005207', 'term': 'Fasciculation'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D013390', 'term': 'Succinylcholine'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lbye@iu.edu', 'phone': '317-274-0275', 'title': 'Dr. Leighan Bye, Assistant Professor of Clinical Anesthesia', 'organization': 'IU school of Medicine, Department of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours post succinylcholine administration', 'eventGroups': [{'id': 'EG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Myalgias Perceived at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'OG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'OG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'classes': [{'categories': [{'title': 'Patients with no pain 3 hours post succinylcholine', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}, {'title': 'Patients who described having pain 3 hours post succinylcholine', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 hours post succinylcholine administration', 'description': 'The data are reported as pain (scores 1-4) vs. no pain (score 0).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myalgias at 24 Hours Post Succinylcholine Administration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'OG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'OG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'classes': [{'categories': [{'title': 'patients experiencing no pain 24 hours post succinylcholine administrations', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}, {'title': 'Patients experiencing pain at 24 hours post succinylcholine administrations', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post succinylcholine administration', 'description': 'The presence of myalgias referencing a severity scale from 0 (no muscle pain), 1 (mild muscle pain), 2(moderate muscle pain), 3 (Moderate muscle pain) and 4 (Severe muscle pain). The data are reported as pain (scores 1-4) vs. no pain (score 0)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'OG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'OG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'classes': [{'title': 'Pain score =0', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Pain score = 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Pain score = 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pain score = 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain score = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 hours post succinylcholine administration', 'description': '0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'OG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'OG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'classes': [{'title': '24 hour pain scores = 0', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': '24 hour pain scores=1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': '24 hour pain score=2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '24 pain score =3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '24 pain score=4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post succinylcholine administration.', 'description': '0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'OG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'OG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately following succinylcholine administration up to 2 minutes', 'description': 'Observed presence or absence of muscle fasciculation following succinylcholine administration in subjects pretreated with rocuronium 1 minute prior to succinylcholine administration or 2 minutes prior to succinylcholine administration compared to the control group not pretreated with rocuronium.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Not Pretreated With Rocuronium', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'FG001', 'title': 'Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'FG002', 'title': 'Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Not Pretreated', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment\n\nnon-pretreated Succinylcholine: no pretreatment'}, {'id': 'BG001', 'title': 'Pre-treated 1 Minute Before Succinylcholine Administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment\n\nsuccinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment'}, {'id': 'BG002', 'title': 'Pre-treated 2 Minutes Before Succinylcholine Administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment\n\nsuccinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '15', 'groupId': 'BG000'}, {'value': '62', 'spread': '14', 'groupId': 'BG001'}, {'value': '59', 'spread': '16', 'groupId': 'BG002'}, {'value': '60', 'spread': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Patients age is collected upon consent as part of the demographics to be used to validate cohorts variables between arms of the study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'sex/gender is collected at enrollment to use in demographic analysis between cohort groups.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'There is a total of 290 participants, randomized to a control arm and 2 experimental arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-19', 'size': 183725, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-22T12:13', 'hasProtocol': True}, {'date': '2022-05-23', 'size': 156041, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-19T12:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization will be performed using Research Randomizer in blocks of 30. The primary investigator will inform the person doing the case as to what group the participants are randomized. Both the participants and the research staff doing assessments will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2020-09-25', 'resultsFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-23', 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myalgias Perceived at 3 Hours', 'timeFrame': '3 hours post succinylcholine administration', 'description': 'The data are reported as pain (scores 1-4) vs. no pain (score 0).'}, {'measure': 'Myalgias at 24 Hours Post Succinylcholine Administration.', 'timeFrame': '24 hours post succinylcholine administration', 'description': 'The presence of myalgias referencing a severity scale from 0 (no muscle pain), 1 (mild muscle pain), 2(moderate muscle pain), 3 (Moderate muscle pain) and 4 (Severe muscle pain). The data are reported as pain (scores 1-4) vs. no pain (score 0)'}, {'measure': 'Pain Scores', 'timeFrame': '3 hours post succinylcholine administration', 'description': '0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.'}, {'measure': 'Pain Scores', 'timeFrame': '24 hours post succinylcholine administration.', 'description': '0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration', 'timeFrame': 'immediately following succinylcholine administration up to 2 minutes', 'description': 'Observed presence or absence of muscle fasciculation following succinylcholine administration in subjects pretreated with rocuronium 1 minute prior to succinylcholine administration or 2 minutes prior to succinylcholine administration compared to the control group not pretreated with rocuronium.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myalgias', 'Fasciculations', 'succinylcholine', 'rocuronium', 'pretreatment', 'precurarization'], 'conditions': ['Myalgia']}, 'referencesModule': {'references': [{'pmid': '16571955', 'type': 'BACKGROUND', 'citation': 'Martyn J, Durieux ME. Succinylcholine: new insights into mechanisms of action of an old drug. Anesthesiology. 2006 Apr;104(4):633-4. doi: 10.1097/00000542-200604000-00004. No abstract available.'}, {'pmid': '10651675', 'type': 'BACKGROUND', 'citation': 'Wong SF, Chung F. Succinylcholine-associated postoperative myalgia. Anaesthesia. 2000 Feb;55(2):144-52. doi: 10.1046/j.1365-2044.2000.055002144.x.'}, {'type': 'BACKGROUND', 'citation': 'Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.'}, {'pmid': '2139549', 'type': 'BACKGROUND', 'citation': 'Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.'}, {'pmid': '9429043', 'type': 'BACKGROUND', 'citation': 'Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.'}, {'pmid': '9669004', 'type': 'BACKGROUND', 'citation': 'Martin R, Carrier J, Pirlet M, Claprood Y, Tetrault JP. Rocuronium is the best non-depolarizing relaxant to prevent succinylcholine fasciculations and myalgia. Can J Anaesth. 1998 Jun;45(6):521-5. doi: 10.1007/BF03012701.'}, {'pmid': '16192781', 'type': 'BACKGROUND', 'citation': 'Schreiber JU, Lysakowski C, Fuchs-Buder T, Tramer MR. Prevention of succinylcholine-induced fasciculation and myalgia: a meta-analysis of randomized trials. Anesthesiology. 2005 Oct;103(4):877-84. doi: 10.1097/00000542-200510000-00027.'}, {'pmid': '20201179', 'type': 'BACKGROUND', 'citation': 'Abbas N, Tariq S, Khan AW, Murtaza G, Naqvi N, Khanzada A. To asses the effects of rocuronium pretreatment on succinylcholine induced fasciculations and postoperative myalgias. J Pak Med Assoc. 2009 Dec;59(12):847-50.'}, {'pmid': '25006369', 'type': 'BACKGROUND', 'citation': 'Kim KN, Kim KS, Choi HI, Jeong JS, Lee HJ. Optimal precurarizing dose of rocuronium to decrease fasciculation and myalgia following succinylcholine administration. Korean J Anesthesiol. 2014 Jun;66(6):451-6. doi: 10.4097/kjae.2014.66.6.451. Epub 2014 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Succinylcholine is a medication (depolarizing muscle relaxant) that is used as part of an anesthetic (going to sleep for surgery). This medication can cause significant muscle soreness. Rocuronium is a medication (non-depolarizing muscle relaxant) that some anesthesia providers believe may reduce muscle soreness caused by succinylcholine if given prior, but this has been controversial. Some anesthesiologists pretreat patients with rocuronium before giving patients succinylcholine, and some do not. The purpose of this study is to examine the effect of pretreatment with rocuronium on muscle soreness associated with succinylcholine administration.', 'detailedDescription': 'After IRB approval from Indiana University Hospital and with written and verbal informed consent from each patient, 300 ASA I, II and III outpatients scheduled for elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia will be enrolled in this randomized-controlled study. The participants and the study personnel performing post-op assessments will be blinded. Anesthesia providers cannot be blinded during this study since anesthesia providers will be required to draw up the study drugs as well as managing the wait time between rocuronium and succinylcholine. Patients are assigned to one of three groups (n = 100 each group). Each participant will undergo a standard IV induction of anesthesia (Lidocaine 1mg/kg, propofol 1-2 mg/kg titrated to effect, and succinylcholine (administered as indicated by study group assignment). Study group details are as follows: Group 1 (Control) to receive no rocuronium pretreatment and 1 mg/kg of succinylcholine. Groups 2 and 3 to receive 0.05 mg/kg up to 5 mg of rocuronium; patients ranged from 50-120 kg. In Group 2, succinylcholine administration will occur at 1.0 mg/kg at t = 1 minute after pretreatment with rocuronium. In Group 3, succinylcholine will be administered (1.0 mg/kg) at t = 2 minutes after pretreatment. The Succinylcholine-induced fasciculations will be noted on study assessment data sheet as either present or absent. . Myalgia assessment is to occur post-succinylcholine administration at t =3 hours and t = 24 hours and will be rated as described below.\n\nMyalgia assessment:\n\nParticipants will by queried at the above time points about muscle pain and scored based on their answers as follows.\n\n0 - no pain /no muscle stiffness\n\n1. \\- mild muscle pain and/or stiffness at 1 or more sites that does not limit daily activity\n2. \\- Moderate muscle pain and/or stiffness at 1 or more sites that does not limit daily activity\n3. \\- Moderate generalized muscle pain and/or stiffness limiting daily activity\n4. \\- Severe muscle pain and/or stiffness at 1 or more sites limiting movement and preventing daily activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia\n* Have been informed of the nature of the study and informed consent has been obtained\n\nExclusion Criteria:\n\n* Patients will be excluded if they have chronic pain requiring daily opioid use greater than 30 mg PO morphine equivalent.\n* Patients will also be excluded if their comorbid medical conditions require a true rapid sequence induction as precurarization with rocuronium increases the time to intubation which is undesirable in a patient who is at high risk for aspiration.\n* Patients taking muscle relaxants at home for spasticity.\n* Patients under the age of 18 years old.\n* Any contraindication for using succinylcholine or rocuronium.'}, 'identificationModule': {'nctId': 'NCT04581395', 'briefTitle': 'The Effect of Pretreatment With Roc on Succinylcholine Myalgias', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'The Effect of Precurarization With Rocuronium on the Incidence and Severity of Succinylcholine-Induced Fasciculations and Myalgias in a High Volume ERCP Center', 'orgStudyIdInfo': {'id': '1912284619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Not pretreated', 'description': 'Succinylcholine administration with no Rocuronium pre-treatment', 'interventionNames': ['Other: non-pretreated Succinylcholine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-treated 1 minute before succinylcholine administration', 'description': 'Succinylcholine administration 1 minute following Rocuronium pre-treatment', 'interventionNames': ['Drug: succinylcholine 1 minute after rocuronium pretreatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-treated 2 minutes before succinylcholine administratjion', 'description': 'Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment', 'interventionNames': ['Drug: succinylcholine 2 minutes following rocuronium pretreatment']}], 'interventions': [{'name': 'non-pretreated Succinylcholine', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'no pretreatment', 'armGroupLabels': ['Not pretreated']}, {'name': 'succinylcholine 1 minute after rocuronium pretreatment', 'type': 'DRUG', 'otherNames': ['rocuronium pretreatment 1 minute before succinylcholine administration'], 'description': '0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment', 'armGroupLabels': ['Pre-treated 1 minute before succinylcholine administration']}, {'name': 'succinylcholine 2 minutes following rocuronium pretreatment', 'type': 'DRUG', 'otherNames': ['rocuronium pretreatment 2 minutes before succinylcholine administration'], 'description': '0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.', 'armGroupLabels': ['Pre-treated 2 minutes before succinylcholine administratjion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Leighan Bye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of clinical Anesthesiology', 'investigatorFullName': 'Leighan S. Bye, MD, PhD', 'investigatorAffiliation': 'Indiana University'}}}}