Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT03955406
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2019-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Flow Anesthesia Without Initial High Flow Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time required to reach 0.7 MAC', 'timeFrame': 'perioperative'}, {'measure': 'number of adjustments made to the vaporizer settings', 'timeFrame': 'perioperative', 'description': 'MAC will be held between 0.6-0.8 with adjustments at the vaporizer'}], 'secondaryOutcomes': [{'measure': 'anesthetic agent consumption', 'timeFrame': 'perioperative', 'description': 'desfluane consumption at the first hour and at the end of the surgery wil be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Flow Anesthesia', 'Volatile Anesthetic Consumption']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007%2Fs10877-018-0135-2', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3\n* scheduled for surgery under general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* hemodynamic instability\n* emergency cases\n* expected anesthesia duration \\< 60 min\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT03955406', 'briefTitle': 'Low Flow Anesthesia Without Initial High Flow Phase', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Comparison of Low Flow Anesthesia With and Without Initial High Flow Phase', 'orgStudyIdInfo': {'id': 'KSU 2017-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', 'description': 'After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 6% with fresh gas flow rate 4 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 1% higher value than the EtAA concentration required to achieve 0.7 MAC. And after 10 minutes fresh gas flow rate will be reduced to 1L/min.', 'interventionNames': ['Procedure: Conventional Low flow Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed Fresh Gas Flow Rate group', 'description': 'After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 18% with fresh gas flow rate 1 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 2% higher value than the EtAA concentration required to achieve 0.7 MAC.', 'interventionNames': ['Procedure: Low Flow Anesthesia with fixed fresh gas flow rate']}], 'interventions': [{'name': 'Conventional Low flow Anesthesia', 'type': 'PROCEDURE', 'description': 'During the initial wash-in period 4 L/min Fresh gas flow will be used.', 'armGroupLabels': ['Conventional group']}, {'name': 'Low Flow Anesthesia with fixed fresh gas flow rate', 'type': 'PROCEDURE', 'description': 'Fresh gas flow rate will be 1 L/min throughout the procedure.', 'armGroupLabels': ['Fixed Fresh Gas Flow Rate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Kahramanmaraş', 'state': 'In the USA Or Canada, Please Select...', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaras Sutcu Imam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'MAHMUT ARSLAN', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}