Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 5:57 PM
Study NCT ID:
NCT05512559
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Composition Analysis and Time to Emergence From Remimazolam
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': 90}, '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': '2022-08-21', 'studyFirstSubmitQcDate': '2022-08-21', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'emergence time', 'timeFrame': 'at the time of emergence', 'description': 'relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion.'}], 'secondaryOutcomes': [{'measure': 'time to loss of consciousness', 'timeFrame': 'at the time of induction', 'description': 'relationship between body composition analysis information and time to loss of consciousness after starting remimazolam infusion.'}, {'measure': 'hypotension', 'timeFrame': 'from induction to emergence of anesthesia', 'description': 'relationship between body composition analysis information and hypotensive event during anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Remimazolam', 'Body Composition']}, 'descriptionModule': {'briefSummary': 'Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. We believe that information from body composition analysis may be helpful in understanding which patients are more likely to show delayed emergence from remimazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam\n\nExclusion Criteria:\n\n* Patients with preoperative mental change, hemodynamic instability, hemodialysis, heart failure, hypoalbuminemia, pregnancy'}, 'identificationModule': {'nctId': 'NCT05512559', 'briefTitle': 'Body Composition Analysis and Time to Emergence From Remimazolam', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Value of Body Composition Analysis in Predicting Delayed Emergence From Remimazolam-based General Anesthesia: A Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'SMC 2022-06-074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'remimazolam', 'description': 'general anesthesia induction with 6mg/kg/hr continuous infusion of remimazolam. general anesthesia maintenance with 1mg/kg/hr continuous infusion of remimazolam.', 'interventionNames': ['Device: body composition analysis']}], 'interventions': [{'name': 'body composition analysis', 'type': 'DEVICE', 'description': 'Body composition analysis by bioelectrical impedance measurement, just before induction of anesthesia.', 'armGroupLabels': ['remimazolam']}]}, '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': 'Professor', 'investigatorFullName': 'Jong Hwan Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}