The Impact of Frailty and Different Sedation Techniques on Cognitive Function in Geriatric Colonoscopy Patients
Conditions: Cognition, Sedation, Geriatric Anesthesia, Frailty, Colonoscopy
Sponsor: Ankara City Hospital Bilkent

 
 
 
 
The Impact of Frailty and Different Sedation Techniques on 
Cognitive Function in Geriatric Colonoscopy Patients 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT Number: 07384169 
Document Type: Study Protocol 
Ethics Committee Approval Date: 19 July 2023 
 
 
 
 

Brief Description 
This prospective, observational study evaluates the impact of frailty status and different sedation techniques on 
postoperative cognitive function in geriatric patients undergoing elective colonoscopy. Cognitive changes are 
assessed using the Mini-Mental State Examination (MMSE) at predefined time points. 
Study Design 
Study Type: Observational 
Study Design: Prospective cohort study 
Allocation: Non-randomized 
Study Setting: Single-center endoscopy unit 
Participants 
Inclusion Criteria: Age ≥65 years, elective colonoscopy, ASA physical status I–III, provision of written informed 
consent 
Exclusion Criteria: Second- or third-degree atrioventricular (AV) block, a recent history of strokes, severe 
hypotension, cardiorespiratory instability, substance abuse or psychotic illness, severe dementia, emergency 
colonoscopy. Development of major procedural or anesthetic complications (bleeding, perforation, respiratory 
arrest, or cardiac arrest 
Frailty Assessment 
Frailty status is assessed preoperatively using the FRAIL scale, and patients are categorized according to frailty 
classification 
Sedation Management 
The choice of sedative agent is made by the attending anesthesiologist based on clinical judgment. 
Propofol group: Loading dose of 0.2–0.5 mg/kg IV followed by intermittent bolus dosing as required 
Dexmedetomidine group: Loading dose of 0.5 µg/kg IV administered over 10 minutes 
All patients receive fentanyl 0.5 µg/kg IV. Sedation depth is maintained at a Ramsay Sedation Score of 3–4. 
Outcome Measures 
Primary Outcome: Change in cognitive function assessed by Mini Mental State Examination scores 
Time Frame: baseline (pre-procedure), 2 hours post-procedure, and 24 hours post-procedure Mini Mental State 
Examination scores can be between 0-30. >10 severe impairment, 10-19 moderate dementia 19-24 early dementia 
25 ≤normal 
Secondary Outcomes: Frailty was assessed using the Clinical Frailty Scale prior to colonoscopy.  
Time Frame: baseline (pre-procedure) Frail scores can be between 0-5. O normal, 1-2 Pre-frail, 3-5 Frail 
Statistical Analysis 
Continuous variables are assessed for normality using appropriate methods. Data are summarized as mean ± 
standard deviation or median (minimum–maximum). Between-group comparisons are performed using parametric 
or non-parametric tests as appropriate. Repeated measurements are analyzed using Friedman’s test with Bonferroni 
correction for multiple comparisons. Statistical significance is set at p < 0.05. 
Ethical Considerations 

The study is conducted in accordance with the Declaration of Helsinki and was approved by the local Ethics 
Committee. Written informed consent is obtained from all participants prior to enrollment.