Postoperative Cognitive Deficit (POCD)AECGSKD002NCT07302061
"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
An observational study of Postoperative Cognitive Deficit (POCD), run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Deficit (POCD)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Jun 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing Lower extremity surgery
Who may be able to join
- Patients over the age of 65
- Patients with an American Society of Anesthesiologists (ASA) score of II-III
- Patients with a Mini Mental State Examination (MMSE) score of ≥24 on the first day before surgery
Who cannot join
- Patients with coagulation disorders
- Patients with a history of anticoagulant medication use
- Patients with advanced organ failure
- Patients with Alzheimer's disease or advanced dementia
- Patients with allergies to the medications used in the study
- Mental Retardation
Show all 9Show fewer
- Patients with a wound infection at the site of spinal anesthesia
- Patients with a history of cerebrovascular hemorrhage
- Patients who did not consent;
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe training and research hospital
Istanbul, Kadikoy, 34744
About this study
We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these patients. In this study, we aimed to investigate the effects of different anesthesia techniques (general anesthesia/spinal anesthesia) applied in orthopedic cases on patient fluid status (pleth variablity index) and regional cerebral oxygenation (NIRS), and their relationship with cognitive dysfunction.
- Conditions
- Postoperative Cognitive Deficit (POCD)
- Keywords
- POCD
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 |
|---|---|---|
| General Anesthesia | Not described | |
| Spinal anesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative period (24th and 48th hours) cognitive dysfunction rate
We will assess postoperative cognitive dysfunction.Cognitive function will be evaluated using the MOCA (Montreal Cognitive Assessment) at 24 and 48 hours after surgery.
Measured: Up to 48 hours after operation
Secondary outcomes (1)
Pleth Variability Index (PVI, %) to assess intraoperative fluid status
PVI values will be continuously recorded using non-invasive monitor.
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Aug 2025
- Primary completion15 Dec 2025
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Deficit (POCD)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aygul Valiyeva, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302061
- Sponsor's protocol ID
- AECGSKD002
- Acronym
- AECGSKD002
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
- ClinicalTrials.gov ID
- NCT07302061
- Acronym / sponsor ID
- AECGSKD002 / AECGSKD002
- Conditions
- Postoperative Cognitive Deficit (POCD)
- Keywords
- POCD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these patients. In this study, we aimed to investigate the effects of different anesthesia techniques (general anesthesia/spinal anesthesia) applied in orthopedic cases on patient fluid status (pleth variablity index) and regional cerebral oxygenation (NIRS), and their relationship with cognitive dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | – |
| Spinal anesthesia | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing Lower extremity surgery
Key inclusion criteria (3 listed)
- Patients over the age of 65
- Patients with an American Society of Anesthesiologists (ASA) score of II-III
- Patients with a Mini Mental State Examination (MMSE) score of ≥24 on the first day before surgery
Key exclusion criteria (9 listed)
- Patients with coagulation disorders
- Patients with a history of anticoagulant medication use
- Patients with advanced organ failure
- Patients with Alzheimer's disease or advanced dementia
- Patients with allergies to the medications used in the study
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
Early postoperative period (24th and 48th hours) cognitive dysfunction rate
Time frame: Up to 48 hours after operation
We will assess postoperative cognitive dysfunction.Cognitive function will be evaluated using the MOCA (Montreal Cognitive Assessment) at 24 and 48 hours after surgery.
1 secondary outcome
Pleth Variability Index (PVI, %) to assess intraoperative fluid status
Time frame: During Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Cognitive Deficit (POCD), run by Goztepe 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Early postoperative period (24th and 48th hours) cognitive dysfunction rate (time frame: Up to 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.