General AnesthesiaNCT07505550
The Effect of Positive End-Expiratory Pressure Levels on Perfusion Index and Neurocognitive Functions in Geriatric Patients
A study testing PEEP levels in people with General Anesthesia and Elective Laparoscopic Cholecystectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
With the increasing geriatric population, age-related physiological changes and common comorbidities increase the risk of surgical and anesthesia-related complications in this patient group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- General Anesthesia, Elective Laparoscopic Cholecystectomy
- What is being tested?
- PEEP levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2025to 29 Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients who are 65 years and older
- Patients in the ASA I-III risk group
- Under elective conditions, patients those undergo elective laparoscopic cholecystectomy
- Voluntary patients
Who cannot join
- Patients under age 65
- Emergency surgical procedures
- Patients with neurological or psychiatric disorders
- Patients with severe restrictive or obstructive lung disease
- Patients with serious cardiac pathology (EF<40 or presence of arrhythmia)
- Patients with peripheral artery disease
Show all 9Show fewer
- Patients with increased intracranial pressure
- Morbidly obese patients
- Patients do not want to participate in the study
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: Investigation of the Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Perfusion Index (PI) and Neurocognitive Functions in Geriatric Patients Undergoing Laparoscopic Cholecystectomy Surgery
With the increasing geriatric population, age-related physiological changes and common comorbidities increase the risk of surgical and anesthesia-related complications in this patient group. Therefore, careful planning of anesthesia management and ventilation strategies is crucial to achieve safe and successful clinical outcomes. Positive end-expiratory pressure (PEEP), one of these strategies, should be applied with careful consideration of the balance between ensuring oxygenation and maintaining cardiovascular stability in geriatric patients. Early detection of hypoperfusion during the intraoperative period is also an important part of perioperative management. To this end, near-infrared spectroscopy (NIRS) is used as a noninvasive monitoring method to assess cerebral oxygenation, while the perfusion index (PI) is used to evaluate peripheral circulation, providing clinicians with valuable information for predicting potential complications. However, one of the most important neurological complications that can occur after surgery in geriatric patients is postoperative cognitive dysfunction (POCD). The Mini-Mental State Examination (MMSE) is widely preferred for assessing cognitive function during the perioperative period due to its ease of application and reliability.
The primary objective of this study is to investigate the effects of different PEEP levels on PI in geriatric patients undergoing laparoscopic cholecystectomy and to reveal changes in neurocognitive function by comparing preoperative and postoperative MMSE scores. Our secondary objectives are to evaluate the effects of PEEP on NIRS values and to analyze the possible relationships between NIRS, PI, hemodynamic parameters, and MMSE scores.
Read the detailed description
This study was conducted at the General Surgery Operating Room of Ankara Bilkent City Hospital, Ministry of Health, Turkey, with a total of 78 patients aged 65 years and older who were scheduled to undergo elective laparoscopic cholecystectomy. The study was designed as a prospective randomized controlled trial. Using a computer-assisted randomization method, the 78 patients were divided into three groups. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP. On the day of surgery, patients' age, gender, height, weight, body mass index (BMI), comorbidities, medications taken regularly, surgical history, and education level were recorded using a standardized data form in the preoperative waiting area. The Mini Mental State Examination (MMSE) was administered to all patients 2 hours before surgery. After patients were taken to the operating room, noninvasive arterial blood pressure, electrocardiography (ECG), and pulse oximetry were performed as part of standard monitoring. Additionally, four-channel frontal EEG-based SedLine® (Patient State Index, PSI; Masimo Corporation, Irvine, CA, USA) monitoring was used to monitor anesthesia depth, and NIRS (O3® regional oximetry, Masimo Corporation, Irvine, CA, USA) monitoring was used to assess cerebral oxygenation. After cleaning the forehead area with an appropriate antiseptic, the SedLine® PSI electrode and O3® NIRS sensors were placed, and baseline values were recorded. For peripheral perfusion monitoring, the PI probe (Masimo Rainbow® Pulse CO-Oximetry, Masimo Corporation, Irvine, CA, USA) was placed on the third finger of the hand without the noninvasive blood pressure cuff. The hand was wrapped to reduce optical interference from ambient light and maintain thermal equilibrium. Before anesthesia induction, 3 minutes of preoxygenation was administered with 100% oxygen via a balloon mask. Anesthesia induction was then performed with fentanyl (2 mcg/kg), lidocaine (1 mg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg); midazolam was not administered. After achieving adequate depth of anesthesia, an endotracheal tube of appropriate size was placed in the patient. Ventilator settings were adjusted to a 50:50 oxygen-air mixture and a fresh gas flow of 2 L/min, targeting a tidal volume of 6-8 mL/kg based on ideal body weight and maintaining EtCO₂ within the range of 35-45 mmHg. PEEP was applied at a level determined by randomization in each patient. Anesthesia maintenance was achieved with sevoflurane and remifentanil infusion (0.01-0.1 mcg/kg/min) to maintain a target PSI range of 25-50. An orogastric tube was placed for gastric decompression. The surgical procedure was performed using the standard laparoscopic cholecystectomy technique. Pneumoperitoneum pressure was adjusted and maintained at 10-12 mmHg; the operating table was positioned at approximately 30° reverse Trendelenburg. Operating room temperature was maintained at 18-20 °C. Parameters evaluated (SAP, DAP, MAP, heart rate, SpO₂, PI, PSI, NIRS left and right) before and after anesthesia induction; after intubation; before pneumoperitoneum and at 1, 5, 10, 15, 30, 45, and 60 minutes after the start of pneumoperitoneum; every 30 minutes thereafter; and also at the end of pneumoperitoneum, at the end of surgery, and after extubation. Additionally, the hemoglobin levels at admission and discharge, the total amount of fluid administered, and the duration of anesthesia and surgery were also recorded. For postoperative pain management, patients received standard tramadol 1 mg/kg IV and paracetamol 1 g IV after gallbladder removal. Following the operation, 2 mg/kg sugammadex IV was administered, and patients were extubated once they began spontaneous breathing. After recovery in the operating room, patients were transferred to the postoperative recovery room. On postoperative day 1, patients underwent the MMSE test, and the results were recorded. Additionally, if any complications developed during the postoperative period, this was noted.
- Being tested
- PEEP levels
- Keywords
- Geriatric Patient, Laparoscopic Cholecystectomy, Near Infrared Spectroscopy, Perfusion Index, Positive End-Expiratory Pressure, Post-Operative Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP levelsOther
78 patients undergoing elective surgery in the General Surgery Operating Room were divided into three groups using a computer-assisted randomization method. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP.
| Study group | Role | What they receive |
|---|---|---|
| 5 cmH₂O PEEP Ventilation | Active comparator | Group 5 was ventilated with 5 cmH₂O PEEP. Receives: Other: PEEP levels |
| 7 cmH₂O PEEP Ventilation | Active comparator | Group 7 was ventilated with 7 cmH₂O PEEP. Receives: Other: PEEP levels |
| 9 cmH₂O PEEP Ventilation | Active comparator | Group 9 was ventilated with 9 cmH₂O PEEP. Receives: Other: PEEP levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive functions
The diagnosis of postoperative cognitive dysfunction is based on the evaluation of differences in preoperative and postoperative cognitive performance. One of the most commonly used methods for assessing cognitive functions is the Mini-Mental State Examination (MMSE). The MMSE covers subheadings such as orientation, memory, language, attention, calculation, and recall, and is scored out of 30 points. Results are interpreted as follows: 24-30 points indicate normal cognitive function, 18-23 points indicate mild cognitive impairment, and 0-17 points indicate moderate to severe cognitive impairment.
Measured: 2 hours before the operation and on the first postoperative day, The MMSE test was administered again to patients and the results were recorded.
Evaluate changes in perfusion index (PI)
Perfusion index (PI) is defined as the ratio of the pulsatile signal obtained by photoplethysmography to the nonpulsatile signal. Photoplethysmography is a noninvasive, rapidly applicable method widely used in intraoperative patient monitoring. PI is an indirect indicator of central and peripheral perfusion and is primarily determined by the sympathetic-parasympathetic balance that regulates cardiac output and vascular tone. Changes in PI were evaluated at different applied PEEP levels.
Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
Secondary outcomes (4)
Evaluate changes in near infrared spectroscopy (NIRS)
NIRS is a method that uses near-infrared spectroscopy technology to noninvasively assess the oxygenation status of tissues. In NIRS monitoring, an initial rSO₂ level below 40% or a decrease of more than 25% from the baseline measurement is considered indicative of cerebral ischemia. Changes in NIRS were evaluated at different applied PEEP levels.
Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between NIRS and hemodynamic data
Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between PI and hemodynamic data
Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between PI and MMSE scores
PI was recorded before and after anesthesia induction; 1 minute after intubation; before pneumoperitoneum; at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum; and at the end of pneumoperitoneum and surgery. MMSE was assessed 2 hours before surgery and on postoperative day 1.
Measured: 2 hours before surgery through postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start2 Apr 2025
- Primary completion15 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Özayar, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505550
- Sponsor's protocol ID
- Geriatric and PEEP
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 1 Apr 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Perfusion Index (PI) and Neurocognitive Functions in Geriatric Patients Undergoing Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT07505550
- Acronym / sponsor ID
- Geriatric and PEEP
- Keywords
- Geriatric Patient, Laparoscopic Cholecystectomy, Near Infrared Spectroscopy, Perfusion Index, Positive End-Expiratory Pressure, Post-Operative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 1 Apr 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.
With the increasing geriatric population, age-related physiological changes and common comorbidities increase the risk of surgical and anesthesia-related complications in this patient group. Therefore, careful planning of anesthesia management and ventilation strategies is crucial to achieve safe and successful clinical outcomes. Positive end-expiratory pressure (PEEP), one of these strategies, should be applied with careful consideration of the balance between ensuring oxygenation and maintaining cardiovascular stability in geriatric patients. Early detection of hypoperfusion during the intraoperative period is also an important part of perioperative management. To this end, near-infrared spectroscopy (NIRS) is used as a noninvasive monitoring method to assess cerebral oxygenation, while the perfusion index (PI) is used to evaluate peripheral circulation, providing clinicians with valuable information for predicting potential complications. However, one of the most important neurological complications that can occur after surgery in geriatric patients is postoperative cognitive dysfunction (POCD). The Mini-Mental State Examination (MMSE) is widely preferred for assessing cognitive function during the perioperative period due to its ease of application and reliability.
The primary objective of this study is to investigate the effects of different PEEP levels on PI in geriatric patients undergoing laparoscopic cholecystectomy and to reveal changes in neurocognitive function by comparing preoperative and postoperative MMSE scores. Our secondary objectives are to evaluate the effects of PEEP on NIRS values and to analyze the possible relationships between NIRS, PI, hemodynamic parameters, and MMSE scores.
Detailed description
This study was conducted at the General Surgery Operating Room of Ankara Bilkent City Hospital, Ministry of Health, Turkey, with a total of 78 patients aged 65 years and older who were scheduled to undergo elective laparoscopic cholecystectomy. The study was designed as a prospective randomized controlled trial. Using a computer-assisted randomization method, the 78 patients were divided into three groups. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP. On the day of surgery, patients' age, gender, height, weight, body mass index (BMI), comorbidities, medications taken regularly, surgical history, and education level were recorded using a standardized data form in the preoperative waiting area. The Mini Mental State Examination (MMSE) was administered to all patients 2 hours before surgery. After patients were taken to the operating room, noninvasive arterial blood pressure, electrocardiography (ECG), and pulse oximetry were performed as part of standard monitoring. Additionally, four-channel frontal EEG-based SedLine® (Patient State Index, PSI; Masimo Corporation, Irvine, CA, USA) monitoring was used to monitor anesthesia depth, and NIRS (O3® regional oximetry, Masimo Corporation, Irvine, CA, USA) monitoring was used to assess cerebral oxygenation. After cleaning the forehead area with an appropriate antiseptic, the SedLine® PSI electrode and O3® NIRS sensors were placed, and baseline values were recorded. For peripheral perfusion monitoring, the PI probe (Masimo Rainbow® Pulse CO-Oximetry, Masimo Corporation, Irvine, CA, USA) was placed on the third finger of the hand without the noninvasive blood pressure cuff. The hand was wrapped to reduce optical interference from ambient light and maintain thermal equilibrium. Before anesthesia induction, 3 minutes of preoxygenation was administered with 100% oxygen via a balloon mask. Anesthesia induction was then performed with fentanyl (2 mcg/kg), lidocaine (1 mg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg); midazolam was not administered. After achieving adequate depth of anesthesia, an endotracheal tube of appropriate size was placed in the patient. Ventilator settings were adjusted to a 50:50 oxygen-air mixture and a fresh gas flow of 2 L/min, targeting a tidal volume of 6-8 mL/kg based on ideal body weight and maintaining EtCO₂ within the range of 35-45 mmHg. PEEP was applied at a level determined by randomization in each patient. Anesthesia maintenance was achieved with sevoflurane and remifentanil infusion (0.01-0.1 mcg/kg/min) to maintain a target PSI range of 25-50. An orogastric tube was placed for gastric decompression. The surgical procedure was performed using the standard laparoscopic cholecystectomy technique. Pneumoperitoneum pressure was adjusted and maintained at 10-12 mmHg; the operating table was positioned at approximately 30° reverse Trendelenburg. Operating room temperature was maintained at 18-20 °C. Parameters evaluated (SAP, DAP, MAP, heart rate, SpO₂, PI, PSI, NIRS left and right) before and after anesthesia induction; after intubation; before pneumoperitoneum and at 1, 5, 10, 15, 30, 45, and 60 minutes after the start of pneumoperitoneum; every 30 minutes thereafter; and also at the end of pneumoperitoneum, at the end of surgery, and after extubation. Additionally, the hemoglobin levels at admission and discharge, the total amount of fluid administered, and the duration of anesthesia and surgery were also recorded. For postoperative pain management, patients received standard tramadol 1 mg/kg IV and paracetamol 1 g IV after gallbladder removal. Following the operation, 2 mg/kg sugammadex IV was administered, and patients were extubated once they began spontaneous breathing. After recovery in the operating room, patients were transferred to the postoperative recovery room. On postoperative day 1, patients underwent the MMSE test, and the results were recorded. Additionally, if any complications developed during the postoperative period, this was noted.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 cmH₂O PEEP Ventilation | Active comparator | Other: PEEP levelsGroup 5 was ventilated with 5 cmH₂O PEEP. |
| 7 cmH₂O PEEP Ventilation | Active comparator | Other: PEEP levelsGroup 7 was ventilated with 7 cmH₂O PEEP. |
| 9 cmH₂O PEEP Ventilation | Active comparator | Other: PEEP levelsGroup 9 was ventilated with 9 cmH₂O PEEP. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who are 65 years and older
- Patients in the ASA I-III risk group
- Under elective conditions, patients those undergo elective laparoscopic cholecystectomy
- Voluntary patients
Key exclusion criteria (9 listed)
- Patients under age 65
- Emergency surgical procedures
- Patients with neurological or psychiatric disorders
- Patients with severe restrictive or obstructive lung disease
- Patients with serious cardiac pathology (EF<40 or presence of arrhythmia)
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 |
|---|---|---|
| PEEP levels78 patients undergoing elective surgery in the General Surgery Operating Room were divided into three groups using a computer-assisted randomization method. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP. | Other | 5 cmH₂O PEEP Ventilation, 7 cmH₂O PEEP Ventilation, 9 cmH₂O PEEP Ventilation |
Primary outcome
Neurocognitive functions
Time frame: 2 hours before the operation and on the first postoperative day, The MMSE test was administered again to patients and the results were recorded.
The diagnosis of postoperative cognitive dysfunction is based on the evaluation of differences in preoperative and postoperative cognitive performance. One of the most commonly used methods for assessing cognitive functions is the Mini-Mental State Examination (MMSE). The MMSE covers subheadings such as orientation, memory, language, attention, calculation, and recall, and is scored out of 30 points. Results are interpreted as follows: 24-30 points indicate normal cognitive function, 18-23 points indicate mild cognitive impairment, and 0-17 points indicate moderate to severe cognitive impairment.
Evaluate changes in perfusion index (PI)
Time frame: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
Perfusion index (PI) is defined as the ratio of the pulsatile signal obtained by photoplethysmography to the nonpulsatile signal. Photoplethysmography is a noninvasive, rapidly applicable method widely used in intraoperative patient monitoring. PI is an indirect indicator of central and peripheral perfusion and is primarily determined by the sympathetic-parasympathetic balance that regulates cardiac output and vascular tone. Changes in PI were evaluated at different applied PEEP levels.
4 secondary outcomes
Evaluate changes in near infrared spectroscopy (NIRS)
Time frame: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between NIRS and hemodynamic data
Time frame: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between PI and hemodynamic data
Time frame: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.
To determine the possible correlations between PI and MMSE scores
Time frame: 2 hours before surgery through postoperative day 1
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 1 Apr 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?
A study testing PEEP levels in people with General Anesthesia and Elective Laparoscopic Cholecystectomy, 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 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: finished, as of the sponsor's last update on 1 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?
Neurocognitive functions (time frame: 2 hours before the operation and on the first postoperative day, The MMSE test was administered again to patients and the results were recorded.). The study lists 2 primary outcomes in all. 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 1 Apr 2026.