Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-06 @ 11:54 PM
Study NCT ID:
NCT02651792
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2015-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine- Propofol Versus Pethidine- Propofol in ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2015-11-29', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'amount of propofol consumed during procedure', 'timeFrame': 'Immediately after procedure.'}], 'primaryOutcomes': [{'measure': 'endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)', 'timeFrame': 'Immediately after procedure.'}]}, 'conditionsModule': {'keywords': ['ketamine', 'propofol', 'pethidine', 'ERCP', 'endoscopist'], 'conditions': ['Sedation in ERCP']}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.', 'detailedDescription': 'The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to \\<90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both gender\n* age between 18-70\n\nExclusion Criteria:\n\n* pregnant patients.\n* morbid obesity.\n* chronic obstructive pulmonary disease.\n* complicated airway.\n* American society of anesthesia (ASA) physical classification IV-V.\n* history of allergy or contraindications to the drugs used in the study\n* emergency need for ERCP.\n* those whose informed consent could not be signed.\n* those with possible complex ERCP.'}, 'identificationModule': {'nctId': 'NCT02651792', 'briefTitle': 'Ketamine- Propofol Versus Pethidine- Propofol in ERCP', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'orgStudyIdInfo': {'id': 'ketfol versus pethidine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine- propofol', 'description': 'IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.', 'interventionNames': ['Drug: ketamine- propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pethidine- propofol', 'description': '1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction', 'interventionNames': ['Drug: pethidine- propofol']}], 'interventions': [{'name': 'ketamine- propofol', 'type': 'DRUG', 'otherNames': ['N01AX03 - Propofol'], 'description': '1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.', 'armGroupLabels': ['ketamine- propofol']}, {'name': 'pethidine- propofol', 'type': 'DRUG', 'otherNames': ['meperidine - Propofol'], 'description': '1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction', 'armGroupLabels': ['pethidine- propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Al Rajhy liver hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mostafa S Abbas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia and ICU', 'investigatorFullName': 'khaled salah mohamed', 'investigatorAffiliation': 'Assiut University'}}}}