Cognitive Function in Geriatric Colonoscopy Patients

NCT07384169 | Completed

• 1 other identifier: E2-23-4566
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Procedures such as colonoscopy cause discomfort and pain and are therefore performed under sedation and analgesia. Although patients aged 65 and older frequently undergo colonoscopy procedures, it is unclear to what extent the anesthetic agents administered for sedation and analgesia in this patient group affect neurocognitive functions. Different sedation methods are used in colonoscopy procedures depending on the anesthesiologist's choice. Propofol is an agent frequently used in general anesthesia or for sedation during endoscopic procedures and, compared to inhaled agents, has more positive effects on postoperative cognitive functions. Dexmedetomidine is an alpha receptor agonist and is preferred due to its positive effects on cognitive functions in elderly patients, its lack of respiratory depression, its ability to provide sedation without impairing cooperation, and its analgesic effects. Although there are studies in the literature on the assessment of neurocognitive function in geriatric patients undergoing surgical procedures, the literature is insufficient in terms of studies addressing cognitive assessment after short-term, outpatient, and less invasive procedures such as colonoscopy. This study aimed to observe patients aged 65 years and older who underwent sedoanalgesia for colonoscopy and to compare the effects on cognitive function by administering the mini mental test before and after the procedure to this patient group.

Conditions

Sedation; Frailty; Geriatric Anesthesia; Colonoscopy; Cognition

Keywords

FRAIL; COGNITIVE FUNCTION; GERIATRIC ANESTHESIA; COLONOSKOPY

Outcome Measures

Primary Outcomes (1)

• Assessment of Cognitive Function

  Change in cognitive function assessed by Mini Mental State Examination scores. Mini Mental State Examination scores can be between 0-30. \>10 severe impairment, 10-19 moderate dementia 19-24 early dementia 25 ≤normal

  Baseline (pre-procedure), 2 hours post-procedure, and 24 hours post-procedure

Secondary Outcomes (1)

• Frailty Score

  Baseline (pre-procedure)

Study Arms (2)

Propofol

Aged 65 years and older who received propofol

Drug: Propofol Group

Dexmedetomidine

Aged 65 years and older who received 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).The patient was administered a loading dose of dexmedetomidine 0.5 μg/kg-1 over 10 minutes. Propofol 0.1 μg/kg bolus was administered to patients as needed.

Also known as: D Group

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).propofol loading dose: 0.2-0.5 mg/kg, continued as repeated boluses for maintenance.

Also known as: P Group

Propofol

Eligibility Criteria

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

Study Population

65 years and older

You may qualify if:

• Age ≥65 years
• Elective colonoscopy
• ASA physical status I-III
• Provision of written informed consent

You may not qualify if:

• Second- or third-degree atrioventricular (AV) block
• A recent history of strokes
• Severe hypotension
• Cardiorespiratory instability
• Substance abuse
• Psychotic illness
• Severe dementia

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• Chen M, Sun Y, Li X, Zhang C, Huang X, Xu Y, Gu C. Effectiveness of single loading dose of dexmedetomidine combined with propofol for deep sedation of endoscopic retrograde cholangiopancreatography (ERCP) in elderly patients: a prospective randomized study. BMC Anesthesiol. 2022 Mar 28;22(1):85. doi: 10.1186/s12871-022-01630-8.

  PMID: 35346041 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

• 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

• Allampati S, Wen S, Liu F, Kupec JT. Recovery of cognitive function after sedation with propofol for outpatient gastrointestinal endoscopy. Saudi J Gastroenterol. 2019 May-Jun;25(3):188-193. doi: 10.4103/sjg.SJG_369_18.

  PMID: 30618439 RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filiz Kaya, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: August 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

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

Locations

TU (1)