Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT02676934
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
End Tidal Control of Sevoflurane
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']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cost of sevoflurane during anesthesia', 'timeFrame': 'Intra-operative period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia of Living Donor Hepatectomy']}, 'descriptionModule': {'briefSummary': 'the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as effective as FGF control with less cost and more operator satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all donors scheduled for living donor hepatectomy in Mansoura liver transplant program\n\nExclusion Criteria:\n\n* refusal'}, 'identificationModule': {'nctId': 'NCT02676934', 'acronym': 'EtCntrl', 'briefTitle': 'End Tidal Control of Sevoflurane', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'R-ETCNTRL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Et group', 'description': 'applying end tidal concentration as a control target for delivery of sevoflurane', 'interventionNames': ['Device: End tidal control module in Aisys anesthesia workstation']}, {'type': 'NO_INTERVENTION', 'label': 'FGF group', 'description': 'using Fresh gas control for sevoflurane delivery'}], 'interventions': [{'name': 'End tidal control module in Aisys anesthesia workstation', 'type': 'DEVICE', 'description': 'THE USE OF AUTOMATED CONTROL OF END TIDAL SEVOFLURANE CONCENTRATION TO MAINTAIN ANESTHESIA DURING DONOR HEPATECTOMY', 'armGroupLabels': ['Et group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62215', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}