Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT04997967
Status:
UNKNOWN
Last Update Posted:
2021-08-10
First Post:
2021-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2021-07-11', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of ketofol in sedation', 'timeFrame': '24 hours', 'description': 'The time to reach Ramsay Sedation Scale score of 5 to ensure adequate sedation. This scale is between 1-6.\n\nThe score 5 and 6 indicates adequate sedation while score \\<5 indicates inadequate sedation.'}], 'secondaryOutcomes': [{'measure': 'Impact of ketofol on hemodynamics', 'timeFrame': '24 hours', 'description': 'Heart rate (beats/min)'}, {'measure': 'Impact of ketofol on oxygen saturation', 'timeFrame': '24 hours', 'description': 'Pulse oximeter (SO2)'}, {'measure': 'Impact of ketofol on hemodynamics', 'timeFrame': '24 hours', 'description': 'Blood pressure(mmHg)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Conscious Sedation Failure During Procedure']}, 'descriptionModule': {'briefSummary': 'Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.', 'detailedDescription': 'This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe acute cholangitis of either sex\n* Aged between 21-70 years\n* Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.\n\nExclusion Criteria:\n\n* Patients who had ASA physical status Grade VI,\n* Baseline SpO2 \\<90%,\n* Patients who had difficulty in communication,\n* Patients allergic to the studied medications,\n* Morbidly obese patients,\n* Patients with chronic obstructive pulmonary disease,\n* Complicated airway,\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT04997967', 'briefTitle': 'Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Ketofol in Urgent ERCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketofol group', 'description': 'Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Will receive Ketofol (ketamine: propofol concentration 1:4) prepared in 50 ml syringe containing dextrose 5% (each ml contained 8 mg propofol and 2 mg ketamine), administered as following; 5 ml of ketofol as loading then infusion titrated till targeted RSS score.', 'interventionNames': ['Drug: Ketamine/Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Ketamine/Propofol', 'type': 'DRUG', 'description': 'The level of sedation was assessed at 1-3 min intervals, and the infusion rate was adjusted accordingly to achieve a Ramsay Sedation Scale (RSS) score of 5. Any movement of the patient was treated by increasing infusion rate and the infusion was discontinued at the end of the procedure. The total propofol consumed was calculated and the recovery time was recorded and calculated as the time from discontinuation of infusion of the study drug till achievement of RSS score of 3. Then patients were discharged to post-anesthesia care unit (PACU) after attaining an Aldrete Recovery Scale Score of 9- 10 \\[19\\]. Time taken to achieve this score was also recorded.', 'armGroupLabels': ['Ketofol group']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Haidi Ramadan, rofessor', 'role': 'CONTACT', 'email': 'haidikaram@aun.edu.eg', 'phone': '+0201028186710'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Haidi Ramadan, Phd', 'role': 'CONTACT', 'email': 'haidikaram@aun.edu.eg', 'phone': '+201028186710'}], 'overallOfficials': [{'name': 'Haidi Ramadan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Direct contact with the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Haidi Karam', 'investigatorAffiliation': 'Assiut University'}}}}