Clinical trial NCT06719960: How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?
Official title: How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition
Sedation for Gastroenteric Endoscopic Procedure
Geriatric Patients
Keywords: FRAIL
COGNITIVE FUNCTION
ERCP
PROPOFOL
DEXMEDETOMIDINE
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 184
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients processed at Ankara Bilkent City Hospital ERCP unit

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.

Eligibility criteria: 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

Primary outcomes:
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
name: FİLİZ KAYA, MD.
role: STUDY_CHAIR
References:
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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.
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.