Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 9:11 AM
Study NCT ID:
NCT01091350
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2010-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2010-03-14', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated effect-site propofol concentration at loss of consciousness', 'timeFrame': 'after propofol infusion'}], 'secondaryOutcomes': [{'measure': 'Time to loss of consciousness', 'timeFrame': 'after propofol infusion'}]}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing general anesthesia\n\nExclusion Criteria:\n\n* Hepatic or renal disease\n* Drug addiction'}, 'identificationModule': {'nctId': 'NCT01091350', 'briefTitle': 'Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness', 'orgStudyIdInfo': {'id': 'Orchestra vs Diprifusor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diprifusor group', 'description': 'Propofol was infused via Diprifusor TCI (Target-controlled infusion)', 'interventionNames': ['Device: Diprifusor (Target-controlled infusion)']}, {'type': 'EXPERIMENTAL', 'label': 'Orchestra group', 'description': 'Propofol was infused via Orchestra TCI', 'interventionNames': ['Device: Orchestra (Target-controlled infusion)']}], 'interventions': [{'name': 'Diprifusor (Target-controlled infusion)', 'type': 'DEVICE', 'otherNames': ['Diprifusor(Grasby Medical Limited, United Kingdom)'], 'description': 'Two TCI devices with different Teo and same Marsh PK model', 'armGroupLabels': ['Diprifusor group']}, {'name': 'Orchestra (Target-controlled infusion)', 'type': 'DEVICE', 'otherNames': ['OrchestraTM (Fresenius Vial, Brezins, France)'], 'description': 'Two TCI devices with different Teo and same Marsh PK model', 'armGroupLabels': ['Orchestra group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jung-Won Hwang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}