CognitionNCT06719960
How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?
An observational study of Cognition and Sedation for Gastroenteric Endoscopic Procedure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognition, Sedation for Gastroenteric Endoscopic Procedure, Geriatric Patients
- What is being tested?
- Dexmedetomidine group and Propofol group
- Type of treatment
- Injection or infusion
- How many people
- 184 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 26 Feb 2024
- How long will I take part?
- 1 Day
- 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: Patients processed at Ankara Bilkent City Hospital ERCP unit
Who may be able to join
- Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.
Who cannot join
- Patients with 2nd and 3rd degree Atrioventricular Block,
- Recent history of stroke
- Severe hypotensive
- Cardiorespiratory instability
- Substance abuse
- Psychotic illness
- Severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?
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.
Read the detailed description
Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.
Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. 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. 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. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.
- Being tested
- Dexmedetomidine group, Propofol group
- Keywords
- FRAIL, COGNITIVE FUNCTION, ERCP, PROPOFOL, DEXMEDETOMIDINE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine groupDrug
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.
Propofol groupDrug
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.
| 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 propofol + dexmedetomidine Receives: Drug: Dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of cognitive function
Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start20 Jul 2023
- Primary completion20 Dec 2023
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FİLİZ KAYA, MD., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719960
- Sponsor's protocol ID
- E2-23-4565
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2024
- Last updated
- 6 Dec 2024
- 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
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.
PubMed 25460022Lei 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.
PubMed 32076394Mei 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 31714323Sun 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.
PubMed 39193191Kaya F, Ozayar E, Ozcan ATD, Ucar M, Ozturk L. How are cognitive functions affected by different sedation methods in geriatric endoscopic retrograde cholangiopancreatography patients? BMC Anesthesiol. 2025 Dec 10;26(1):39. doi: 10.1186/s12871-025-03555-4.
PubMed 41372755
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?
- ClinicalTrials.gov ID
- NCT06719960
- Acronym / sponsor ID
- E2-23-4565
- Keywords
- FRAIL, COGNITIVE FUNCTION, ERCP, PROPOFOL, DEXMEDETOMIDINE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 6 Dec 2024 (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.
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.
Detailed description
Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.
Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. 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. 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. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- 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 propofol + dexmedetomidine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients processed at Ankara Bilkent City Hospital ERCP unit
Key inclusion criteria (1 listed)
- Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.
Key exclusion criteria (7 listed)
- Patients with 2nd and 3rd degree Atrioventricular Block,
- Recent history of stroke
- Severe hypotensive
- 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 |
|---|---|---|
| Dexmedetomidine 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). 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. | Drug | Dexmedetomidine |
| Propofol 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). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. | Drug | Propofol |
Primary outcome
Assesment of cognitive function
Time frame: 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)
Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded
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 6 Dec 2024.
- 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 32076394Lei 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.
- 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 39193191Sun 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.
- Derived from this study: PubMed 41372755Kaya F, Ozayar E, Ozcan ATD, Ucar M, Ozturk L. How are cognitive functions affected by different sedation methods in geriatric endoscopic retrograde cholangiopancreatography patients? BMC Anesthesiol. 2025 Dec 10;26(1):39. doi: 10.1186/s12871-025-03555-4.
- 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.
FİLİZ KAYA, MD. study chair
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 for Gastroenteric Endoscopic Procedure, 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 1 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 6 Dec 2024. 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?
Assesment of cognitive function (time frame: 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)). 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 NCT06719960, which also lists 5 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 6 Dec 2024.