Postoperative Cognitive DysfunctionNCT07438249
GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery
An observational study of Postoperative Cognitive Dysfunction and Geriatrics, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative cognitive decline remains a common and clinically significant complication among geriatric patients undergoing major abdominal cancer surgery. Age-related physiological vulnerability, impaired cerebral autoregulation, and perioperative hemodynamic instability contribute to the development of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Geriatrics, Abdominal Neoplasm
- What is being tested?
- Masimo Root Hemodynamic Monitoring
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Mar 2026
- 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: The study population consists of geriatric patients (aged 65 and older) scheduled for elective major abdominal cancer surgery at the University of Health Sciences, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Participants will be selected from patients who meet the inclusion criteria and provide informed consent during their preoperative evaluation in the anesthesiology clinic
Who may be able to join
- Age ≥ 65 years (geriatric patients)
- Scheduled for elective major abdominal cancer surgery
- American Society of Anesthesiologists (ASA) Physical Status I-IV
- Eastern Cooperative Oncology Group (ECOG/WHO/Zubrod) performance status ≥ 2
- Ability to complete cognitive assessments
- Provision of written informed consent
Who cannot join
- Severe cardiac dysfunction (Cardiac Index ≤ 2.2 L/min/m²)
- History of neurological or psychiatric disorders (e.g., dementia, Alzheimer's disease)
- Use of medications that significantly affect cognitive function
- Severe hepatic or renal failure
- Prior chemotherapy or radiotherapy before surgery
- Intraoperative or perioperative blood transfusion
- Prolonged mechanical ventilation (inability to extubate immediately after surgery)
- Pre-existing cognitive impairment (baseline Mini-Mental State Examination [MMSE] score < 24)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
About this study
Official title: Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study
Postoperative cognitive decline remains a common and clinically significant complication among geriatric patients undergoing major abdominal cancer surgery. Age-related physiological vulnerability, impaired cerebral autoregulation, and perioperative hemodynamic instability contribute to the development of postoperative neurocognitive impairment.
Goal-directed fluid therapy (GDFT), guided by dynamic hemodynamic parameters, has been proposed as an individualized approach to optimize tissue perfusion while avoiding both hypovolemia and fluid overload. Non-invasive monitoring technologies, such as pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the risks associated with invasive monitoring, making them particularly suitable for elderly surgical populations.
Read more
This prospective observational cohort study aims to evaluate the association between intraoperative PVI/PI-guided GDFT and postoperative cognitive outcomes in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to routine clinical practice, either with individualized GDFT or conventional fluid therapy, as determined by the attending anesthesiologist.
The primary outcome is the change in cognitive function, assessed using Mini-Mental State Examination (MMSE) scores from baseline to postoperative day 1 and postoperative day 7. Longitudinal changes in cognitive function will be analyzed using adjusted statistical models to account for repeated measurements over time and potential confounding factors, including age, ASA physical status, duration of surgery, and intraoperative blood loss.
Secondary outcomes include intraoperative fluid administration, hemodynamic parameters, estimated blood loss, and net fluid balance. The study is designed to provide clinically relevant evidence on whether individualized, non-invasive hemodynamic monitoring strategies are associated with improved perioperative physiological stability and early postoperative cognitive recovery in elderly surgical patients.
Read the detailed description
Postoperative neurocognitive disorders, including early postoperative cognitive decline, represent a significant source of morbidity in geriatric patients undergoing major abdominal cancer surgery. These impairments are multifactorial and are thought to arise from the interaction of perioperative hemodynamic instability, impaired cerebral autoregulation, systemic inflammatory responses, and age-related reductions in physiological reserve.
Among perioperative factors, intraoperative fluid management plays a central role in maintaining adequate tissue perfusion and organ function. Both hypovolemia and fluid overload have been associated with adverse outcomes, including impaired microcirculatory perfusion and potential effects on cerebral oxygen delivery. Traditional fluid management strategies, typically based on fixed formulas and static physiological parameters, may not adequately reflect inter-individual variability, particularly in elderly patients with altered cardiovascular compliance and limited adaptive capacity.
Goal-directed fluid therapy (GDFT) has emerged as an individualized hemodynamic management strategy aimed at optimizing stroke volume and tissue perfusion through the use of dynamic indicators of fluid responsiveness. While randomized trials and meta-analyses have demonstrated that GDFT can improve perioperative outcomes such as complication rates and length of hospital stay, its impact on postoperative cognitive outcomes remains insufficiently characterized, especially in oncologic geriatric populations.
Recent advances in non-invasive hemodynamic monitoring technologies, including the use of pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the need for invasive cardiac output monitoring. These tools offer a practical and safer alternative in routine clinical practice, particularly in elderly patients where invasive monitoring may not always be feasible.
This study is designed as a prospective observational cohort study conducted in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to standard clinical practice, and intraoperative fluid management strategy-either PVI/PI-guided GDFT or conventional fluid therapy-is determined by the attending anesthesiologist. No intervention is assigned by the study protocol, and no modification of routine clinical care is performed.
The primary objective of the study is to evaluate the association between intraoperative fluid management strategy and postoperative cognitive trajectory. Cognitive function is assessed using the Mini-Mental State Examination (MMSE) at three time points: preoperatively (baseline), postoperative day 1, and postoperative day 7. The primary outcome is defined as the change in MMSE scores over time.
To appropriately account for repeated cognitive measurements and potential confounding, longitudinal statistical models will be employed. Specifically, mixed-effects modeling will be used to evaluate the interaction between time and fluid management strategy, while adjusting for clinically relevant covariates, including age, ASA physical status, duration of surgery, and intraoperative blood loss.
Secondary objectives include evaluating the association between fluid management strategy and intraoperative physiological parameters, including total fluid administered, mean arterial pressure, heart rate, estimated blood loss, and net fluid balance.
Given the observational nature of the study, results will be interpreted as associations rather than causal effects. The study aims to generate clinically relevant evidence regarding whether individualized, non-invasive, goal-directed fluid strategies are associated with improved early postoperative cognitive recovery and optimized perioperative physiological stability in geriatric surgical patients.
- Being tested
- Masimo Root Hemodynamic Monitoring
- Medical subject headings
- Postoperative Cognitive Complications, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Root Hemodynamic MonitoringDevice
Use of PVI and PI parameters to guide intraoperative fluid titration.
| Study group | Role | What they receive |
|---|---|---|
| GDFT Group (Masimo Root Guided) | Patients in this group will receive intraoperative GDFT. Hemodynamic monitoring will be performed using the Masimo Root device. Fluid administration (crystalloids and/or colloids) will be titrated based on real-time PVI and PI values to maintain optimal stroke volume and tissue perfusion. The goal is to achieve individualized hemodynamic stability throughout the major abdominal cancer surgery. Receives: Device: Masimo Root Hemodynamic Monitoring | |
| Conventional Group (Standard Care) | Patients in this group will receive conventional fluid therapy based on standard clinical guidelines. Fluid requirements will be calculated using the traditional "4:2:1" rule (physiological requirement + estimated blood loss + third-space fluid loss). Intraoperative fluid management will rely on routine monitoring (heart rate, mean arterial pressure, and urine output) without the use of advanced hemodynamic parameters like PVI or PI from the Masimo Root device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postoperative Cognitive Function (MMSE Scores)
The primary outcome is the assessment of cognitive function using the Mini-Mental State Examination. The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, where lower scores indicate greater cognitive impairment (e.g., <24 is typically considered indicative of cognitive dysfunction). The study will compare the incidence of POCD between the GDFT group (monitored via Masimo Root PVI/PI) and the conventional fluid therapy group.
Measured: Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.
Secondary outcomes (6)
Total Intraoperative Fluid Volume
Total volume of intravenous fluids administered during surgery, including crystalloids, colloids, and blood products.
Measured: From induction of anesthesia to the end of surgery (assessed intraoperatively, up to approximately 4 hours)
Intraoperative Mean Arterial Pressure (MAP)
Mean arterial pressure values recorded at predefined intraoperative time points to assess hemodynamic stability
Measured: Baseline (pre-induction), intraoperative 1st hour, intraoperative 2nd hour
Intraoperative Heart Rate (HR)
Heart rate measurements recorded during surgery as an indicator of cardiovascular response
Measured: Intraoperative period (baseline, 1st hour, 2nd hour)
Estimated Blood Loss
Total estimated intraoperative blood loss recorded by the anesthesia and surgical team
Measured: Intraoperative period
Net Fluid Balance
Difference between total fluid input (intravenous fluids) and output (urine output and estimated blood loss).
Measured: From induction of anesthesia to the end of surgery (calculated at the end of surgery, over an intraoperative period of up to approximately 4 hours).
Change in Mean Arterial Pressure Over Time
Longitudinal change in MAP across intraoperative time points to evaluate hemodynamic trends
Measured: Baseline, intraoperative 1st hour, intraoperative 2nd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438249
- Sponsor's protocol ID
- 2024-11/723
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as per the ethical committee approval and institutional policies. Only aggregated study results will be published.
Publications
Wu B, Guo Y, Min S, Xiong Q, Zou L. Postoperative cognitive dysfunction in elderly patients with colorectal cancer: A randomized controlled study comparing goal-directed and conventional fluid therapy. Open Med (Wars). 2024 Mar 27;19(1):20240930. doi: 10.1515/med-2024-0930. eCollection 2024.
PubMed 38584828Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.
PubMed 29678619Zhang J, Qiao H, He Z, Wang Y, Che X, Liang W. Intraoperative fluid management in open gastrointestinal surgery: goal-directed versus restrictive. Clinics (Sao Paulo). 2012 Oct;67(10):1149-55. doi: 10.6061/clinics/2012(10)06.
PubMed 23070341
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study
- ClinicalTrials.gov ID
- NCT07438249
- Acronym / sponsor ID
- 2024-11/723
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 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.
Postoperative cognitive decline remains a common and clinically significant complication among geriatric patients undergoing major abdominal cancer surgery. Age-related physiological vulnerability, impaired cerebral autoregulation, and perioperative hemodynamic instability contribute to the development of postoperative neurocognitive impairment.
Goal-directed fluid therapy (GDFT), guided by dynamic hemodynamic parameters, has been proposed as an individualized approach to optimize tissue perfusion while avoiding both hypovolemia and fluid overload. Non-invasive monitoring technologies, such as pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the risks associated with invasive monitoring, making them particularly suitable for elderly surgical populations.
This prospective observational cohort study aims to evaluate the association between intraoperative PVI/PI-guided GDFT and postoperative cognitive outcomes in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to routine clinical practice, either with individualized GDFT or conventional fluid therapy, as determined by the attending anesthesiologist.
The primary outcome is the change in cognitive function, assessed using Mini-Mental State Examination (MMSE) scores from baseline to postoperative day 1 and postoperative day 7. Longitudinal changes in cognitive function will be analyzed using adjusted statistical models to account for repeated measurements over time and potential confounding factors, including age, ASA physical status, duration of surgery, and intraoperative blood loss.
Secondary outcomes include intraoperative fluid administration, hemodynamic parameters, estimated blood loss, and net fluid balance. The study is designed to provide clinically relevant evidence on whether individualized, non-invasive hemodynamic monitoring strategies are associated with improved perioperative physiological stability and early postoperative cognitive recovery in elderly surgical patients.
Detailed description
Postoperative neurocognitive disorders, including early postoperative cognitive decline, represent a significant source of morbidity in geriatric patients undergoing major abdominal cancer surgery. These impairments are multifactorial and are thought to arise from the interaction of perioperative hemodynamic instability, impaired cerebral autoregulation, systemic inflammatory responses, and age-related reductions in physiological reserve.
Among perioperative factors, intraoperative fluid management plays a central role in maintaining adequate tissue perfusion and organ function. Both hypovolemia and fluid overload have been associated with adverse outcomes, including impaired microcirculatory perfusion and potential effects on cerebral oxygen delivery. Traditional fluid management strategies, typically based on fixed formulas and static physiological parameters, may not adequately reflect inter-individual variability, particularly in elderly patients with altered cardiovascular compliance and limited adaptive capacity.
Goal-directed fluid therapy (GDFT) has emerged as an individualized hemodynamic management strategy aimed at optimizing stroke volume and tissue perfusion through the use of dynamic indicators of fluid responsiveness. While randomized trials and meta-analyses have demonstrated that GDFT can improve perioperative outcomes such as complication rates and length of hospital stay, its impact on postoperative cognitive outcomes remains insufficiently characterized, especially in oncologic geriatric populations.
Recent advances in non-invasive hemodynamic monitoring technologies, including the use of pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the need for invasive cardiac output monitoring. These tools offer a practical and safer alternative in routine clinical practice, particularly in elderly patients where invasive monitoring may not always be feasible.
This study is designed as a prospective observational cohort study conducted in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to standard clinical practice, and intraoperative fluid management strategy-either PVI/PI-guided GDFT or conventional fluid therapy-is determined by the attending anesthesiologist. No intervention is assigned by the study protocol, and no modification of routine clinical care is performed.
The primary objective of the study is to evaluate the association between intraoperative fluid management strategy and postoperative cognitive trajectory. Cognitive function is assessed using the Mini-Mental State Examination (MMSE) at three time points: preoperatively (baseline), postoperative day 1, and postoperative day 7. The primary outcome is defined as the change in MMSE scores over time.
To appropriately account for repeated cognitive measurements and potential confounding, longitudinal statistical models will be employed. Specifically, mixed-effects modeling will be used to evaluate the interaction between time and fluid management strategy, while adjusting for clinically relevant covariates, including age, ASA physical status, duration of surgery, and intraoperative blood loss.
Secondary objectives include evaluating the association between fluid management strategy and intraoperative physiological parameters, including total fluid administered, mean arterial pressure, heart rate, estimated blood loss, and net fluid balance.
Given the observational nature of the study, results will be interpreted as associations rather than causal effects. The study aims to generate clinically relevant evidence regarding whether individualized, non-invasive, goal-directed fluid strategies are associated with improved early postoperative cognitive recovery and optimized perioperative physiological stability in geriatric surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDFT Group (Masimo Root Guided) | – | Device: Masimo Root Hemodynamic MonitoringPatients in this group will receive intraoperative GDFT. Hemodynamic monitoring will be performed using the Masimo Root device. Fluid administration (crystalloids and/or colloids) will be titrated based on real-time PVI and PI values to maintain optimal stroke volume and tissue perfusion. The goal is to achieve individualized hemodynamic stability throughout the major abdominal cancer surgery. |
| Conventional Group (Standard Care) | – | –Patients in this group will receive conventional fluid therapy based on standard clinical guidelines. Fluid requirements will be calculated using the traditional "4:2:1" rule (physiological requirement + estimated blood loss + third-space fluid loss). Intraoperative fluid management will rely on routine monitoring (heart rate, mean arterial pressure, and urine output) without the use of advanced hemodynamic parameters like PVI or PI from the Masimo Root device |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of geriatric patients (aged 65 and older) scheduled for elective major abdominal cancer surgery at the University of Health Sciences, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Participants will be selected from patients who meet the inclusion criteria and provide informed consent during their preoperative evaluation in the anesthesiology clinic
Key inclusion criteria (6 listed)
- Age ≥ 65 years (geriatric patients)
- Scheduled for elective major abdominal cancer surgery
- American Society of Anesthesiologists (ASA) Physical Status I-IV
- Eastern Cooperative Oncology Group (ECOG/WHO/Zubrod) performance status ≥ 2
- Ability to complete cognitive assessments
Key exclusion criteria (8 listed)
- Severe cardiac dysfunction (Cardiac Index ≤ 2.2 L/min/m²)
- History of neurological or psychiatric disorders (e.g., dementia, Alzheimer's disease)
- Use of medications that significantly affect cognitive function
- Severe hepatic or renal failure
- Prior chemotherapy or radiotherapy before surgery
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 |
|---|---|---|
| Masimo Root Hemodynamic MonitoringUse of PVI and PI parameters to guide intraoperative fluid titration. | Device | GDFT Group (Masimo Root Guided) |
Primary outcome
Change in Postoperative Cognitive Function (MMSE Scores)
Time frame: Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.
The primary outcome is the assessment of cognitive function using the Mini-Mental State Examination. The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, where lower scores indicate greater cognitive impairment (e.g., <24 is typically considered indicative of cognitive dysfunction). The study will compare the incidence of POCD between the GDFT group (monitored via Masimo Root PVI/PI) and the conventional fluid therapy group.
6 secondary outcomes
Total Intraoperative Fluid Volume
Time frame: From induction of anesthesia to the end of surgery (assessed intraoperatively, up to approximately 4 hours)
Intraoperative Mean Arterial Pressure (MAP)
Time frame: Baseline (pre-induction), intraoperative 1st hour, intraoperative 2nd hour
Intraoperative Heart Rate (HR)
Time frame: Intraoperative period (baseline, 1st hour, 2nd hour)
Estimated Blood Loss
Time frame: Intraoperative period
Net Fluid Balance
Time frame: From induction of anesthesia to the end of surgery (calculated at the end of surgery, over an intraoperative period of up to approximately 4 hours).
Change in Mean Arterial Pressure Over Time
Time frame: Baseline, intraoperative 1st hour, intraoperative 2nd hour
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 30 Apr 2026.
- Background: PubMed 38584828Wu B, Guo Y, Min S, Xiong Q, Zou L. Postoperative cognitive dysfunction in elderly patients with colorectal cancer: A randomized controlled study comparing goal-directed and conventional fluid therapy. Open Med (Wars). 2024 Mar 27;19(1):20240930. doi: 10.1515/med-2024-0930. eCollection 2024.
- Background: PubMed 29678619Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.
- Background: PubMed 23070341Zhang J, Qiao H, He Z, Wang Y, Che X, Liang W. Intraoperative fluid management in open gastrointestinal surgery: goal-directed versus restrictive. Clinics (Sao Paulo). 2012 Oct;67(10):1149-55. doi: 10.6061/clinics/2012(10)06.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as per the ethical committee approval and institutional policies. Only aggregated study results will be published.
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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 Dysfunction and Geriatrics, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 6 inclusion and 8 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 30 Apr 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?
Change in Postoperative Cognitive Function (MMSE Scores) (time frame: Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.). 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 NCT07438249, which also lists 3 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 30 Apr 2026.