Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-02 @ 6:41 AM
Study NCT ID:
NCT00446420
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2007-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2007-03-08', 'studyFirstSubmitQcDate': '2007-03-08', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive impairment at hospital discharge after elective outpatient colonoscopy', 'timeFrame': 'Before discharge from daycare facility'}], 'secondaryOutcomes': [{'measure': 'Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care', 'timeFrame': 'Before discharge from daycare facility'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '19617584', 'type': 'DERIVED', 'citation': 'Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.\n\n200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.', 'detailedDescription': 'A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation\n\nExclusion Criteria:\n\n* No cognitive impairment\n* Adequate English language comprehension\n* Not combined with other procedures'}, 'identificationModule': {'nctId': 'NCT00446420', 'briefTitle': 'Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'officialTitle': 'Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations', 'orgStudyIdInfo': {'id': '2006.228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'These patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs', 'interventionNames': ['Drug: Propofol, midazolam, fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'These patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.', 'interventionNames': ['Drug: Propofol, midazolam, fentanyl']}], 'interventions': [{'name': 'Propofol, midazolam, fentanyl', 'type': 'DRUG', 'otherNames': ['Diprivan', 'Sublimase', 'Versed'], 'description': "All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy", 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'Kate Leslie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}