CognitionNCT07384169
Cognitive Function in Geriatric Colonoscopy Patients
An observational study of Cognition and Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognition, Sedation, Geriatric Anesthesia
- What is being tested?
- Propofol Group and Dexmedetomidine group
- Type of treatment
- Injection or infusion
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 65 years and older
Who may be able to join
- Age ≥65 years
- Elective colonoscopy
- ASA physical status I-III
- Provision of written informed consent
Who cannot join
- Second- or third-degree atrioventricular (AV) block
- A recent history of strokes
- Severe hypotension
- Cardiorespiratory instability
- Substance abuse
- Psychotic illness
- Severe dementia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognition, Sedation, Geriatric Anesthesia, Frailty, Colonoscopy
- Being tested
- Propofol Group, Dexmedetomidine group
- Keywords
- FRAIL, COGNITIVE FUNCTION, GERIATRIC ANESTHESIA, COLONOSKOPY
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol GroupDrug
Also called P 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.
Dexmedetomidine groupDrug
Also called D 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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Aged 65 years and older who received propofol Receives: Drug: Propofol Group | |
| Dexmedetomidine | Aged 65 years and older who received dexmedetomidine Receives: Drug: Dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (pre-procedure), 2 hours post-procedure, and 24 hours post-procedure
Secondary outcomes (1)
Frailty Score
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
Measured: Baseline (pre-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Aug 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filiz Kaya, M.D., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384169
- Sponsor's protocol ID
- E2-23-4566
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share results after published for one year
Publications
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.
PubMed 35346041Mei 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.
PubMed 31714323Qian 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.
PubMed 25460022Allampati 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.
PubMed 30618439
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Frailty and Different Sedation Techniques on Cognitive Function in Geriatric Colonoscopy Patients
- ClinicalTrials.gov ID
- NCT07384169
- Acronym / sponsor ID
- E2-23-4566
- Conditions
- Cognition, Sedation, Geriatric Anesthesia, Frailty, Colonoscopy
- Keywords
- FRAIL, COGNITIVE FUNCTION, GERIATRIC ANESTHESIA, COLONOSKOPY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Drug: Propofol GroupAged 65 years and older who received propofol |
| Dexmedetomidine | – | Drug: Dexmedetomidine groupAged 65 years and older who received dexmedetomidine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 65 years and older
Key inclusion criteria (4 listed)
- Age ≥65 years
- Elective colonoscopy
- ASA physical status I-III
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Second- or third-degree atrioventricular (AV) block
- A recent history of strokes
- Severe hypotension
- Cardiorespiratory instability
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol GroupAlso: P GroupTo 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. | Drug | Propofol |
| Dexmedetomidine groupAlso: D GroupTo 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. | Drug | Dexmedetomidine |
Primary outcome
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
1 secondary outcome
Frailty Score
Time frame: Baseline (pre-procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 35346041Chen 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.
- Results publication: PubMed 31714323Mei 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.
- Results publication: PubMed 25460022Qian 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.
- Results publication: PubMed 30618439Allampati 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.
- Individual participant dataSharing planned: Yes. The investigators plan to share results after published for one year
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Kaya, M.D. principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition and Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Cognitive Function (time frame: Baseline (pre-procedure), 2 hours post-procedure, and 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07384169, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.