Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT06148103
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-18', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-18', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The quality of painless sedation during colonoscopy.', 'timeFrame': 'From start of procedure to 120 minutes after end of colonoscopy', 'description': "The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS)."}], 'secondaryOutcomes': [{'measure': 'incidence of adverse events, Prevalence of adverse effects', 'timeFrame': 'from start of procedure to 120 minutes after end of colonoscopy', 'description': 'incidence of adverse events, hemodynamic instability, failure to provide adequate sedation.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety and Fear']}, 'descriptionModule': {'briefSummary': 'Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.', 'detailedDescription': 'Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.\n\nPatients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n\n 1. both sexes\n 2. 21-60 years old, with\n 3. ASA physical status -\n* Exclusion Criteria:\n\n * severe cardiovascular or respiratory disease\n * (ASA grade ≥III)\n * pregnancy\n * allergies to the drugs being used\n * known alcohol or substance abuse\n * expected communication difficulties with the patient.'}, 'identificationModule': {'nctId': 'NCT06148103', 'briefTitle': 'A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Zulekha Hospitals'}, 'officialTitle': 'Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '00385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'D group', 'description': 'Patients who received Dexmedetomidine. The starting dose of dexmedetomidine was 1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).', 'interventionNames': ['Drug: Patients who received Dexmedetomodine']}, {'type': 'OTHER', 'label': 'PF group', 'description': 'Patients who received Propofol-Fentanyl infusions. Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.', 'interventionNames': ['Drug: patients who received propofol-fentanyl']}], 'interventions': [{'name': 'Patients who received Dexmedetomodine', 'type': 'DRUG', 'otherNames': ['D group'], 'description': '1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).', 'armGroupLabels': ['D group']}, {'name': 'patients who received propofol-fentanyl', 'type': 'DRUG', 'otherNames': ['PF group'], 'description': 'Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.', 'armGroupLabels': ['PF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12546', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Azhar faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'sameh H Seyam, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor, Anesthesiology, Intensive care and pain management'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zulekha Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}