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

NCT06719960 | Completed

• 1 other identifier: E2-23-4565
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Sedation for Gastroenteric Endoscopic Procedure; Geriatric Patients

Keywords

FRAIL; COGNITIVE FUNCTION; ERCP; PROPOFOL; DEXMEDETOMIDINE

Outcome Measures

Primary Outcomes (1)

• Assesment of cognitive function

  Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded

  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)

Study Arms (2)

Propofol

aged 65 years and older who received propofol

Drug: Propofol group

Dexmedetomidine

aged 65 years and older who received propofol + dexmedetomidine

Drug: Dexmedetomidine group

Interventions

Dexmedetomidine group DRUG

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.

Dexmedetomidine

Propofol group DRUG

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.

Propofol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients processed at Ankara Bilkent City Hospital ERCP unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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: 25460022 RESULT

• 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: 32076394 RESULT

• 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: 31714323 RESULT

• 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.

  PMID: 39193191 RESULT

Study Officials

• FİLİZ KAYA, MD.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 6, 2024
• Study Start: July 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: February 26, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: one year
• Access Criteria: Researchers

Locations

TU (1)