Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-21 @ 1:50 PM
Study NCT ID:
NCT02502032
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005207', 'term': 'Fasciculation'}], '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'}]}, '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': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of fasciculations', 'timeFrame': 'After the injection of succinylcholine for 1.5 minutes'}], 'secondaryOutcomes': [{'measure': 'Side effects of the pretreatment of cisatracurium', 'timeFrame': 'From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes'}, {'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 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': {'conditions': ['Fasciculations']}, 'descriptionModule': {'briefSummary': 'To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.', 'detailedDescription': '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 cisatracurium pretreatments, at intubating time, 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 the contraindications associated with succinylcholine or cisatracurium;\n* Patients taking drugs known to alter the action of neuromuscular blockers;\n* Patients with a body mass index exceeding 30'}, 'identificationModule': {'nctId': 'NCT02502032', 'briefTitle': 'Effects of Cisatracurium on Sccinylcholine-induced Fasciculations', 'organization': {'class': 'OTHER', 'fullName': "Yangzhou No.1 People's Hospital"}, 'officialTitle': 'Effects of Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations', 'orgStudyIdInfo': {'id': 'ZZ0716'}}, '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 groups received different pretreatments of cisatracurium.', 'armGroupLabels': ['Cisatracurium 0.005 mg/kg', 'Cisatracurium 0.01 mg/kg', 'Cisatracurium 0.02 mg/kg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xin-nong Liu, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Yangzhou No. 1 Peoples' Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuan Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zhuan Zhang', 'investigatorAffiliation': "Yangzhou No.1 People's Hospital"}}}}