Cognitive ImpairmentNCT05737459
Sedation and Postoperative Cognitive Functions
An observational study of Cognitive Impairment and Femoral Fractures, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Femoral Fractures
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 31 Dec 2022
- How long will I take part?
- 5 Days
- 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 sedated with ketamine and dexmedetomidine during spinal anesthesia for hip fracture
Who may be able to join
- Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture
- Volunteered to participate in the study
Who cannot join
- Patients who are under the age of 65
- Patients with known histories of dementia
- Patients with Alzheimer's disease
- Patients with central nervous system disease
- Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)
- Patients who underwent surgery under general anesthesia
- Patients who refused to voluntarily participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Atatürk Training and Research Hospital
Izmir, 35360
About this study
Official title: The Effect of Sedation on Postoperative Cognitive Functions in Patients Operated for Hip Fracture Under Spinal Anesthesia
Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.
Read the detailed description
Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.
Sedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.
- Conditions
- Cognitive Impairment, Femoral Fractures
- Keywords
- Cognitive Impairment, Mini mental status test, Hip fractures, Ketamine, dexmedetomidine
- Medical subject headings
- Cognitive Dysfunction, Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group K | Those who have been administered ketamine for perioperative sedation | |
| Group D | Those who have been administered dexmedetomidine for perioperative sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental Status Test
Evaluation of the effect of sedation with ketamine and dexmedetomidine on postoperative cognitive functions by Mini-Mental Status Test
Measured: 6 months
Secondary outcomes (2)
noninvasive mean arterial pressure
The effect of sedation on perioperative hemodynamics.
Measured: 6 months
The heart rate
The effect of sedation on perioperative hemodynamics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 May 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- 82 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital
- Investigators
- Derya A Yurtlu, M.D., Principal investigator, Izmir Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737459
- Sponsor's protocol ID
- IAERH
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cetinkaya AS, Yurtlu DA, Tuzen AS. The effect of sedation methods on early postoperative cognitive decline in patients undergoing hip fracture surgery with spinal anesthesia: a prospective cohort study. BMC Surg. 2026 Apr 1;26(1):324. doi: 10.1186/s12893-026-03706-5.
PubMed 41917926
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedation on Postoperative Cognitive Functions in Patients Operated for Hip Fracture Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05737459
- Acronym / sponsor ID
- IAERH
- Conditions
- Cognitive Impairment, Femoral Fractures
- Keywords
- Cognitive Impairment, Mini mental status test, Hip fractures, Ketamine, dexmedetomidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Feb 2023 (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.
Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.
Detailed description
Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.
Sedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K | – | –Those who have been administered ketamine for perioperative sedation |
| Group D | – | –Those who have been administered dexmedetomidine for perioperative sedation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients sedated with ketamine and dexmedetomidine during spinal anesthesia for hip fracture
Key inclusion criteria (2 listed)
- Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture
- Volunteered to participate in the study
Key exclusion criteria (7 listed)
- Patients who are under the age of 65
- Patients with known histories of dementia
- Patients with Alzheimer's disease
- Patients with central nervous system disease
- Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental Status Test
Time frame: 6 months
Evaluation of the effect of sedation with ketamine and dexmedetomidine on postoperative cognitive functions by Mini-Mental Status Test
2 secondary outcomes
noninvasive mean arterial pressure
Time frame: 6 months
The heart rate
Time frame: 6 months
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 21 Feb 2023.
- Derived from this study: PubMed 41917926Cetinkaya AS, Yurtlu DA, Tuzen AS. The effect of sedation methods on early postoperative cognitive decline in patients undergoing hip fracture surgery with spinal anesthesia: a prospective cohort study. BMC Surg. 2026 Apr 1;26(1):324. doi: 10.1186/s12893-026-03706-5.
- Individual participant dataSharing planned: Undecided
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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.
Derya A Yurtlu, M.D. principal investigator
Izmir Katip Celebi University Atatürk Training and Research Hospital
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 Cognitive Impairment and Femoral Fractures, run by Izmir Ataturk Training and Research Hospital 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 2 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 21 Feb 2023. 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?
Mini-Mental Status Test (time frame: 6 months). 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 NCT05737459, which also lists 1 linked publication.
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 21 Feb 2023.