Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:40 PM
Study NCT ID:
NCT06719960
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-19', 'size': 230726, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-29T05:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assesment of cognitive function', 'timeFrame': 'Maximum 1 day (Mini Mental State Examination scores can be between 0-30. Less than 10 is considered severe impairment, 10-19 is considered moderate dementia, 19-24 is considered early dementia and 25 and above is considered normal)', 'description': 'Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FRAIL', 'COGNITIVE FUNCTION', 'ERCP', 'PROPOFOL', 'DEXMEDETOMIDINE'], 'conditions': ['Cognition', 'Sedation for Gastroenteric Endoscopic Procedure', 'Geriatric Patients']}, 'referencesModule': {'references': [{'pmid': '25460022', 'type': 'RESULT', 'citation': 'Qian XL, Zhang W, Liu MZ, Zhou YB, Zhang JM, Han L, Peng YM, Jiang JH, Wang QD. Dexmedetomidine improves early postoperative cognitive dysfunction in aged mice. Eur J Pharmacol. 2015 Jan 5;746:206-12. doi: 10.1016/j.ejphar.2014.11.017. Epub 2014 Nov 20.'}, {'pmid': '32076394', 'type': 'RESULT', 'citation': 'Lei D, Sha Y, Wen S, Xie S, Liu L, Han C. Dexmedetomidine May Reduce IL-6 Level and the Risk of Postoperative Cognitive Dysfunction in Patients After Surgery: A Meta-Analysis. Dose Response. 2020 Feb 5;18(1):1559325820902345. doi: 10.1177/1559325820902345. eCollection 2020 Jan-Mar.'}, {'pmid': '31714323', 'type': 'RESULT', 'citation': 'Mei B, Xu G, Han W, Lu X, Liu R, Cheng X, Chen S, Gu E, Liu X, Zhang Y; Perioperative Neurocognitive Disorders (PND) Study Group. The Benefit of Dexmedetomidine on Postoperative Cognitive Function Is Unrelated to the Modulation on Peripheral Inflammation: A Single-center, Prospective, Randomized Study. Clin J Pain. 2020 Feb;36(2):88-95. doi: 10.1097/AJP.0000000000000779.'}, {'pmid': '39193191', 'type': 'RESULT', 'citation': 'Sun Z, Shi J, Liu C, Zhang J, Liu Y, Wu Y, Han X, Dai H, Wu J, Bo L, Wang F. The Effect of Low-Dose Dexmedetomidine on Perioperative Neurocognitive Dysfunction in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized, Controlled, Double-Blind Trial. Drug Des Devel Ther. 2024 Aug 23;18:3715-3725. doi: 10.2147/DDDT.S470514. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The investigators wanted to observe the change in the level of consciousness of patients undergoing ERCP after anesthesia. For this, the investigators evaluated the patients with the mini mental state examination test and the frail scale.', 'detailedDescription': 'Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.\n\nMethods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients processed at Ankara Bilkent City Hospital ERCP unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.\n\nExclusion Criteria:\n\n* Patients with 2nd and 3rd degree Atrioventricular Block,\n* Recent history of stroke\n* Severe hypotensive\n* Cardiorespiratory instability\n* Substance abuse\n* Psychotic illness\n* Severe dementia'}, 'identificationModule': {'nctId': 'NCT06719960', 'briefTitle': 'How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?', 'orgStudyIdInfo': {'id': 'E2-23-4565'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propofol', 'description': 'aged 65 years and older who received propofol', 'interventionNames': ['Drug: Propofol group']}, {'label': 'Dexmedetomidine', 'description': 'aged 65 years and older who received propofol + dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine group']}], 'interventions': [{'name': 'Dexmedetomidine group', 'type': 'DRUG', 'description': 'To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Propofol group', 'type': 'DRUG', 'description': 'To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'FİLİZ KAYA, MD.', 'role': 'STUDY_CHAIR'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'one year', 'ipdSharing': 'YES', 'description': 'The investigators plan to share results after published for one year', 'accessCriteria': 'Researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}