Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02481193
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005207', 'term': 'Fasciculation'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101584', 'term': 'cisatracurium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of fasciculations', 'timeFrame': 'After the injection of succinylcholine for 1.5 minutes'}], 'secondaryOutcomes': [{'measure': 'Side effects of the pretreatment of cisatracurium', 'timeFrame': 'At the time of three minutes after the pretreatment of cisatracurium'}, {'measure': 'The time to maximal depression of twitch', 'timeFrame': 'From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes'}, {'measure': 'The extent to maximal depression of twitch', 'timeFrame': 'From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes'}, {'measure': 'The time for twitch recovery to 20% of its control value', 'timeFrame': 'From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes'}, {'measure': 'The grades of endotracheal intubation', 'timeFrame': 'At intubating time'}, {'measure': 'The changes of serum potassium', 'timeFrame': 'After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation'}, {'measure': 'Myalgia at 24 hours postoperatively', 'timeFrame': 'At 24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cisatracurium', 'Myalgia', 'Fasciculation', 'Succinylcholine'], 'conditions': ['Fasciculation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.', 'detailedDescription': 'Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.\n\nMethods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia\n* 20 - 65 years old\n* without acid-base imbalance and electrolyte disturbance\n* with normal hepatic and renal function\n\nExclusion Criteria:\n\n* Patients with known hyperkalemia\n* Patients with increased intraocular pressure\n* Patients with increased intracranial pressure\n* Patients with symptoms of gastroesophageal reflux\n* Patients with anticipated airway difficulties\n* Patients with malignant fever\n* Patients with neuromuscular disease\n* Patients with burn or crush injuries\n* Patients with taking drugs known to alter the action of neuromuscular blockers\n* Patients with with a body mass index exceeding 30'}, 'identificationModule': {'nctId': 'NCT02481193', 'briefTitle': 'Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia', 'organization': {'class': 'OTHER', 'fullName': "Yangzhou No.1 People's Hospital"}, 'officialTitle': 'Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia', 'orgStudyIdInfo': {'id': 'YZYY-610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cisatracurium 0.005 mg/kg', 'description': 'The group received pretreatment of cisatracurium 0.005 mg/kg.', 'interventionNames': ['Drug: Cisatracurium']}, {'type': 'EXPERIMENTAL', 'label': 'Cisatracurium 0.01 mg/kg', 'description': 'The group received pretreatment of cisatracurium 0.01 mg/kg', 'interventionNames': ['Drug: Cisatracurium']}, {'type': 'EXPERIMENTAL', 'label': 'Cisatracurium 0.02 mg/kg', 'description': 'The group received pretreatment of cisatracurium 0.02 mg/kg', 'interventionNames': ['Drug: Cisatracurium']}], 'interventions': [{'name': 'Cisatracurium', 'type': 'DRUG', 'otherNames': ['Dose'], 'description': 'Different doses of cisatracurium pretreatment', 'armGroupLabels': ['Cisatracurium 0.005 mg/kg', 'Cisatracurium 0.01 mg/kg', 'Cisatracurium 0.02 mg/kg']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Yangzhou No.1 People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dongsheng Zhang, MD', 'investigatorAffiliation': "Yangzhou No.1 People's Hospital"}}}}