Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-02 @ 12:53 PM
Study NCT ID:
NCT05515835
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to TOF1', 'timeFrame': 'up to 1 hour after rocuronium administration during induction of anesthesia', 'description': 'correlation between the time from induction to recovery of 1st TOF twitch and age, sex, ASA class, body weight, and body composition analysis data'}, {'measure': 'time to TOF4', 'timeFrame': 'up to 1.5 hour after rocuronium administration during induction of anesthesia', 'description': 'correlation between the time from induction to recovery of 4th TOF twitch and age, sex, ASA class, body weight, and body composition analysis data'}], 'secondaryOutcomes': [{'measure': 'time to loss of TOF', 'timeFrame': 'up to 5 minutes after rocuronium administration during induction of anesthesia', 'description': 'correlation between the time from injection of rocuronium to complete loss of TOF twitch and age, sex, ASA class, body weight, and body composition analysis data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rocuronium', 'Body Composition']}, 'descriptionModule': {'briefSummary': "The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with ASA class I-II undergoing total intravenous general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with ASA class I-II undergoing total intravenous general anesthesia\n\nExclusion Criteria:\n\n* too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium)\n* too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium)\n* pregnancy\n* prediagnosed muscle or nerve related disease\n* unsuitable for body composition analysis using bioelectrical impedance method\n* unsuitable for neuromuscular block monitoring'}, 'identificationModule': {'nctId': 'NCT05515835', 'briefTitle': 'Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.', 'orgStudyIdInfo': {'id': 'SMC 2022-07-160'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rocuronium', 'description': 'The patient will be given 50mg of rocuronium intravenously for induction.', 'interventionNames': ['Device: body composition analysis']}], 'interventions': [{'name': 'body composition analysis', 'type': 'DEVICE', 'description': 'Patients will undergo body composition analysis using bioelectical impedance method before anesthesia.', 'armGroupLabels': ['rocuronium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jong Hwan Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}