Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05693402
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2022-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid-Free Anesthesia in Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative Morphone use', 'timeFrame': 'up to 24 hours', 'description': 'Patients who received Morphine at different time points in function of the two study groups'}, {'measure': 'Time To Extubation (TTE)', 'timeFrame': 'Directly intraOp', 'description': 'Time to Extubation in function of the two study groups'}], 'secondaryOutcomes': [{'measure': 'Post Operative Nausea and Vomiting (PONV)', 'timeFrame': 'Up to 24hours', 'description': 'Patients who had PONV at different times in function of the two study groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Anesthesia', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of opioid-free general anesthesia for breast surgeries in female patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between January 2018 and September 2020, data from admitted patients for modified radical mastectomy under general anesthesia were enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients underwenting modified radical mastectomy\n* Undergoing general anesthesia\n\nExclusion Criteria:\n\n* Patients were excluded if they had Alzheimer's Disease, mental retardation, failure of locoregional anesthesia, contraindication for locoregional anesthesia."}, 'identificationModule': {'nctId': 'NCT05693402', 'briefTitle': 'Opioid-Free Anesthesia in Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Dr Etienne El Helou'}, 'officialTitle': 'Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy', 'orgStudyIdInfo': {'id': 'HelouAssaf'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 consisting of treated patients using OFA', 'description': 'Group 1 consisted of 56 (Mean age was 54±14 years)'}, {'label': 'Group 2 consisting of treated patients using NOFA', 'description': 'Group 2 consisted of 60 patients (Mean age was 51±12 years)', 'interventionNames': ['Procedure: opioid anesthesia']}], 'interventions': [{'name': 'opioid anesthesia', 'type': 'PROCEDURE', 'description': 'opioid-free general anesthesia vs non opioid-free general anesthesia', 'armGroupLabels': ['Group 2 consisting of treated patients using NOFA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Lebanese Hospital Geitaoui-University Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Etienne El Helou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Etienne El Helou', 'investigatorAffiliation': 'Dr Etienne El Helou'}}}}