Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-05 @ 12:25 AM
Study NCT ID:
NCT06756594
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative and postoperative monitoring of sedation during upper or lower gastrointestinal system endoscopy.', 'timeFrame': 'every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.', 'description': 'Sedation level'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Propofol']}, 'referencesModule': {'references': [{'pmid': '33285707', 'type': 'BACKGROUND', 'citation': 'Tekeli AE, Oguz AK, Tuncdemir YE, Almali N. Comparison of dexmedetomidine-propofol and ketamine-propofol administration during sedation-guided upper gastrointestinal system endoscopy. Medicine (Baltimore). 2020 Dec 4;99(49):e23317. doi: 10.1097/MD.0000000000023317.'}, {'pmid': '27284342', 'type': 'BACKGROUND', 'citation': 'Zhang F, Sun HR, Zheng ZB, Liao R, Liu J. Dexmedetomidine versus midazolam for sedation during endoscopy: A meta-analysis. Exp Ther Med. 2016 Jun;11(6):2519-2524. doi: 10.3892/etm.2016.3186. Epub 2016 Mar 24.'}, {'pmid': '28130737', 'type': 'BACKGROUND', 'citation': 'Chang ET, Certal V, Song SA, Zaghi S, Carrasco-Llatas M, Torre C, Capasso R, Camacho M. Dexmedetomidine versus propofol during drug-induced sleep endoscopy and sedation: a systematic review. Sleep Breath. 2017 Sep;21(3):727-735. doi: 10.1007/s11325-017-1465-x. Epub 2017 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare efficacy of sedation between Dexmedetomidine-Propofol and Ketamine-Propofol combinations in the upper or lower gastrointestinal system endoscopy. We compare between 2 combinations as regard hemodynamic stability, post operative side effects as occurrence of delirium, nausea, vomiting, headache, hallucination or agitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I to II.\n* Age between 18 and 60 years.\n* Both sexes.\n\nExclusion Criteria:\n\n* Having severe heart, lung, liver disease, kidney failure, or bleeding disorder.\n* Patients having fever, hypothermia or infection, electrolyte disorders, such as hypokalemia and hypocalcaemia, acid-base disorder, allergy to drugs to be used.'}, 'identificationModule': {'nctId': 'NCT06756594', 'briefTitle': 'Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation During Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': 'Soh-Med-24-11-02MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy', 'description': 'efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.', 'interventionNames': ['Drug: Dexmedetomidine-Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine-Propofol for sedation during gastrointestinal endoscopy', 'description': 'efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.', 'interventionNames': ['Drug: Ketamine-Propofol']}], 'interventions': [{'name': 'Dexmedetomidine-Propofol', 'type': 'DRUG', 'description': 'efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.', 'armGroupLabels': ['Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy']}, {'name': 'Ketamine-Propofol', 'type': 'DRUG', 'description': 'efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.', 'armGroupLabels': ['Ketamine-Propofol for sedation during gastrointestinal endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Ahmed H Hamed, Resident', 'role': 'CONTACT', 'email': 'Ahmedh9996@yahoo.com', 'phone': '01124623298'}, {'name': 'Alhaddad A Mosa, Professor', 'role': 'CONTACT', 'phone': '01019816967'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University', 'investigatorFullName': 'Ahmed Hany Hamed', 'investigatorAffiliation': 'Sohag University'}}}}