Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:16 PM
Study NCT ID:
NCT06355960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Oxygenation and Lung Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenation by the end study', 'timeFrame': 'UP TO 6 HOURE', 'description': 'PaO2/Fraction of inspired oxygen'}], 'secondaryOutcomes': [{'measure': 'Intraoperative dynamic lung compliance', 'timeFrame': 'up to 6 hours', 'description': 'tidal volume/ (peak airway pressure -PEEP)'}, {'measure': 'Intraoperative static lung compliance', 'timeFrame': 'UP TO 6 HOURE', 'description': 'Tidal volume/ (plateau pressure - PEEP)'}, {'measure': 'Physiological dead space', 'timeFrame': 'UP TO 6HOURE', 'description': '1.14 (PaCO2-EtCO2)/ PaCO2-0.005'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Use', 'Dexmedetomidine']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMorbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy\n\nExclusion Criteria:\n\nhistory of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC \\< 70%'}, 'identificationModule': {'nctId': 'NCT06355960', 'briefTitle': 'Effect of Dexmedetomidine on Oxygenation and Lung Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Different Does of Dexmedetomidine on Oxygenation and Lung Mechanics', 'orgStudyIdInfo': {'id': '2024-853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'Dexmedetomidine (Precedex) loadings of 1 μg/kg than continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'interventionNames': ['Drug: GROUP Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Dexmedetomidine (Precedex) loadings of 0.5 μg/kg then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'interventionNames': ['Drug: GROUP B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group C', 'description': 'Dexmedetomidine (Precedex) loadings of 0.25 μg/kg(group C) then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'interventionNames': ['Drug: GROUP C']}], 'interventions': [{'name': 'GROUP Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine (Precedex) loadings of 1 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'armGroupLabels': ['group A']}, {'name': 'GROUP B', 'type': 'DRUG', 'description': 'Dexmedetomidine (Precedex) loadings of 0.5 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'armGroupLabels': ['group B']}, {'name': 'GROUP C', 'type': 'DRUG', 'description': 'Dexmedetomidine (Precedex) loadings of 0.25 μg/kg, then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .', 'armGroupLabels': ['group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr S Wahdan, MD', 'role': 'CONTACT', 'email': 'amrwahdan@kasralainy.edu.eg', 'phone': '00201001422499'}], 'overallOfficials': [{'name': 'Amr s wahdan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university , Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still working'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}