Cognitive Function in Geriatric Colonoscopy Patients

February 6, 2026 updated by: Ankara City Hospital Bilkent

The Impact of Frailty and Different Sedation Techniques on Cognitive Function in Geriatric Colonoscopy Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was observational and prospective, and included 164 hospitalized patients aged 65 years and older who received propofol or dexmedetomidine for sedation during colonoscopy. Patients were admitted to the preparation room in the endoscopy unit 30 minutes before the start of colonoscopy. The patients' age, education level (divided into two separate categories: one group with high school education and above, and the other group with less education), Body Mass Index (BMI), American Society of Anesthesiologists (ASA) risk status, and comorbidities were recorded. To assess cognitive function, the Mini Mental State Examination (MMSE) was administered by an investigator who was unaware of which sedation agent would be administered. The patient's degree of frailty was determined using the Frailty Questionnaire. The MMSE was repeated 2 hours after the colonoscopy procedure was completed and at 24 hours. Patients were monitored in the post-anesthesia recovery room using the Modified Aldrete Scoring System. Assessment was performed at 2 hours after the Aldrete Score reached 10 points. Colonoscopy procedures were performed in two separate rooms by two anesthesiologists using two different sedation methods. In our study, patients were observed by anesthesiologists independent of the study in these two rooms. Patients in both groups were started with 3 L/min O2 via a nasal cannula upon entering the room. Patients were monitored for heart rate (HR), systolic arterial blood pressure (SABP), diastolic arterial blood pressure (DABP), mean arterial blood pressure (MAP), and arterial oxygen saturation (SpO2), and baseline measurements of hemodynamic variables were recorded at 5 min, 10 min, and 15 min. Both groups received 0.5 µg/kg fentanyl (IV). In the propofol group (P), the propofol loading dose was 0.2-0.5 mg/kg, and maintenance was continued with repeated boluses. In the dexmedetomidine (D) group, a loading dose of 0.5 μg/kg-1 dexmedetomidine was administered over 10 minutes. When necessary, patients receive propofol 0.1mg/kg push. Ramsey score was maintained at level 3-4 for effective sedation. Colonoscopy procedure duration, total propofol and dexmedetomidine amounts used, and additional atropine and ephedrine administered were recorded. Medications were discontinued upon completion of colonoscopy. Patients were evaluated using the Modified Aldrete Score in the postoperative recovery room and then transferred to the ward. Patients were excluded from the study if complications such as bleeding, perforation, respiratory arrest, or cardiac arrest developed due to the colonoscopy or anesthesia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

65 years and older

Description

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
  • Psychotic illness
  • Severe dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Propofol
Aged 65 years and older who received propofol
Drug: Propofol Group
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.
Other Names:
  • P Group
Dexmedetomidine
Aged 65 years and older who received dexmedetomidine
Drug: Dexmedetomidine group
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.
Other Names:
  • D Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of Cognitive Function
Time Frame: Baseline (pre-procedure), 2 hours post-procedure, and 24 hours post-procedure

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frailty Score
Time Frame: Baseline (pre-procedure)

Frailty was assessed using the Clinical Frailty Scale prior to colonoscopy. Frail scores can be between 0-5.

O normal, 1-2 Pre-frail, 3-5 Frail
Baseline (pre-procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filiz Kaya, M.D., Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2-23-4566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to share results after published for one year

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

researchers

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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