Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 10:12 PM
Study NCT ID:
NCT02617433
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Muscle Mass and Muscle Relaxation Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time until reoccurrence of response of first stimulus(T1).', 'timeFrame': 'two hours', 'description': 'T1 is obtained by train of four which is commonly used neuromuscular monitoring device.'}], 'primaryOutcomes': [{'measure': 'ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0)', 'timeFrame': 'two hours', 'description': 'T1 and T0 is obtained by train of four which is commonly used neuromuscular monitoring device.'}], 'secondaryOutcomes': [{'measure': 'completely suppression time of result of first stimulus(T1).', 'timeFrame': 'ten minutes', 'description': 'T1 is obtained by train of four which is commonly used neuromuscular monitoring device.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find relationship between muscle mass and muscle relaxation time.', 'detailedDescription': "Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find relationship between muscle mass and muscle relaxation time. Measurement of muscle mass will be obtained using bioelectrical impedence analysis."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient who undergo general anesthesia.\n* Male; weight 70-75kg , height 170-175cm\n* Female; weight 53-58kg , height 158-163cm\n\nExclusion Criteria:\n\n* Liver and kidney disease\n* Any types of muscle disorder.\n* Metal materials or pacemaker in body'}, 'identificationModule': {'nctId': 'NCT02617433', 'briefTitle': 'Relationship Between Muscle Mass and Muscle Relaxation Time', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation', 'orgStudyIdInfo': {'id': 'Inbody'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inbody', 'description': 'Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours.', 'interventionNames': ['Device: Inbody']}], 'interventions': [{'name': 'Inbody', 'type': 'DEVICE', 'description': 'Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.', 'armGroupLabels': ['Inbody']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea university anam hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung Zhoo Yoon, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Go Eun Bae', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical instructor', 'investigatorFullName': 'Go Eun Bae', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}