Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT02618668
Status:
TERMINATED
Last Update Posted:
2019-09-23
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D002761', 'term': 'Cholangitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-28', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography', 'timeFrame': 'every 5 minutes up to 30minutes'}, {'measure': 'saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography', 'timeFrame': 'every 5 minutes up to 30 minutes'}, {'measure': 'Heart rate( beat/minute) from baseline of patient', 'timeFrame': 'every 5 minutes up to 30 minutes'}, {'measure': 'Recovery score of patient', 'timeFrame': 'up to 10 minutes after the end of procedure'}], 'secondaryOutcomes': [{'measure': 'patient and doctor satisfaction score', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'conditionsModule': {'conditions': ['Pancreatitis', 'Cholangitis']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \\& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists ( I ,II )\n\nExclusion Criteria:\n\n1. Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.\n2. History of substance abuse or dependence.\n3. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.\n4. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02618668', 'acronym': 'Assiutu', 'briefTitle': 'Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography', 'orgStudyIdInfo': {'id': 'Momen01098983009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine / Propofol Admixture', 'description': 'Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol.', 'interventionNames': ['Drug: Ketamine / Propofol Admixture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'I.V propofol 2 mg/kg', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Ketamine / Propofol Admixture', 'type': 'DRUG', 'description': 'propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol', 'armGroupLabels': ['Ketamine / Propofol Admixture']}, {'name': 'Propofol', 'type': 'DRUG', 'description': '2 mg/kg I.V', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed A Bakr, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Nagwa m osman, Asst.prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of anesthesia and ICU, Assiut University', 'investigatorFullName': 'm mostfa youssef mekky', 'investigatorAffiliation': 'Assiut University'}}}}