How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?

Completed

• Conditions: Cognition; Sedation for Gastroenteric Endoscopic Procedure; Geriatric Patients
• Interventions: Drug: Propofol group; Drug: Dexmedetomidine group

• Registration Number: NCT06719960
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

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.

Methods: 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.

Study Timeline

• Study Start: 2023-07-20
• Primary Completion: 2023-12-20
• Study Completion: 2024-02-26
• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.

Exclusion Criteria

• Patients with 2nd and 3rd degree Atrioventricular Block,
• Recent history of stroke
• Severe hypotensive
• Cardiorespiratory instability
• Substance abuse
• Psychotic illness
• Severe dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol group	aged 65 years and older who received propofol
Dexmedetomidine	Dexmedetomidine group	aged 65 years and older who received propofol + dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Assesment of cognitive function	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)	Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey