An observational study in POCD - Postoperative Cognitive Dysfunction, Recovery Time and Postoperative Neurocognitive Disorder, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
Among 32 studies in Postoperative Cognitive Complications with a site in Turkey — 6 open to participants now, 8 under way, none of them phase 3. Postoperative Cognitive Complications · Turkey.
Among the 32 studies in Postoperative Cognitive Complications with a site in Turkey, this one is the 13th largest by planned enrollment of the 19 observational ones that give a count, is one of 7 that started in 2025, is one of 19 observational ones, and was the 20th registered.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
Browse Postoperative Cognitive Complications studies →6 of the 32 studies in Postoperative Cognitive Complications with a site in Turkey are open now. Recruiting first, the newest first:
Fatihhan Zeytun · Sites in Turkey
Ages 18+ · Women only
Muğla Sıtkı Koçman University · Sites in Turkey
Ages 65+
Bursa Yuksek Ihtisas Training and Research Hospital · Sites in Turkey
Ages 18–80
Ankara City Hospital Bilkent · Sites in Turkey
Ages 18–40 · Women only · Healthy volunteers
Istinye University · Sites in Turkey
Ages 18–100
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 33 Postoperative Cognitive Complications studies recruiting now, 21 (64%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 100 across 113 observational studies indexed under Postoperative Cognitive Complications.
Median enrollment 80 across the 13 interventional studies, 80 across the 19 observational. Of the 21 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 32 has an industry lead sponsor. The 10 most frequent:
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital has 1 study filed under Postoperative Cognitive Complications — fewer than ten, so there is no comparison to draw.
1 of the studies in Postoperative Cognitive Complications with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07339124Ankara Ataturk Sanatorium Training and Research HospitalThe Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients | 2027-03-15 |
Among the 32 studies in Postoperative Cognitive Complications with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In this study, the investigators want to examine the effects of intravenous anesthetic drugs and gases on cognitive functions in the postoperative period in individuals who will undergo surgery for obesity. The investigators believe that the anesthesia method we apply with inhalation gases is also as reliable method as total intravenous anesthesia for postoperative cognitive functions in these patients who undergoe sleeve gastrectomy.
The anesthesia method applied intravenously and with inahalational gases have been applied safely for many years. Comparisons between these two anesthesia technics in obese individuals and for postoperative cognitive dysfunctions are limited.
Studies on the examination of cognitive functions in postoperative patients have gained momentum with the use of neuropsychiatric tests performed on patients who have undergone cardiac surgery and these tests have also been performed on individuals who have undergone non-cardiac surgery. And yet, similar declines in cognitive functions have been observed. For these reasons, the effects of surgery itself and anesthesia methods on cognitive functions have been studied up to date.
In this study, the investigators plan to evaluate patients who will undergo obesity surgery in both anesthesia methods by the recovery times from anesthesia and the residual effects of anesthesia, and after awakening they plan to evaluate their cognitive functions with neuropsychiatric tests that will be performed at certain intervals.
The aim of this study is to investigate the effects of TIVA (Total Intravenous Anesthesia) and inhalational anesthesia on postoperative cognitive functions in patients undergoing sleeve gastrectomy as a bariatric surgery, to determine the residual effects of anesthetic drugs and to determine recovery times, to observe mental changes caused by the anesthesia method and surgical intervention, to evaluate postoperative cognitive functions with neurocognitive tests, and to try to determine the most appropriate anesthesia method for the patient as the method with faster recovery, better patient comfort and less cognitive function changes. The investigators think that they can safely choose inhalation anesthesia, like TIVA, in patients who will undergo obesity surgery.
The relationships between the choice of anesthesia method and the recovery in obese patients remain unclear. Obesity-related physiological changes, such as increased cardiac output, may affect the pharmacokinetics of anesthetic agents by increasing the volume of distribution and clearance of the drug. However, it is difficult to assess the extent of these changes. In fact, no significant clinical difference has been shown in terms of recovery times between obese and non-obese patients anesthetized with inhalation agents in clinical studies.
TIVA and inhalational anesthesia have been used safely up to date, and both are routinely used in patients undergoing laparoscopic bariatric surgery. Although TIVA was once seen as a promising alternative to inhalational anesthesia; in morbidly obese patients with different clinical and metabolic profiles, the high lipid solubility and slow metabolic elimination of intravenous anesthetics, in addition to manual administration of these drugs, are limited even in computer-controlled automated systems such as TCI (Target Controlled Infusion) devices and CLADS (Closed Loop Anesthesia Delivery System) designed to provide predefined plasma concentrations based on patient response and multi-compartmental pharmacokinetic algorithms.
In another study conducted to determine the optimum anesthesia method in obese patients, TIVA and inhalational anesthesia were applied in sleeve gastrectomy, and TIVA showed better recovery, lower pain scores, lower incidence of postoperative nausea and vomiting, and shorter PACU (Post Anesthesia Care Unit) stay.
A consensus group was formed to develop terminology similar to that used in cognitive classifications of the general population to be used in the investigation of cognitive function changes after anesthesia and surgery. This working group suggested using the term "POND"(Perioperative Neurocognitive Disorders) as a comprehensive term for cognitive disorders defined in the preoperative and postoperative periods, and decided to call the cognitive decline present in the preoperative period "NCD" (Neurocognitive Disorder), the form defined as a clear and acute event within the first 7 days after the effects of postoperative surgery and anesthesia excluded as "Postoperative Delirium", the cognitive decline observed in the time period up to 30 days after surgery "Delayed Neurocognitive Recovery" and the form observed up to 12 months "POCD" (Postoperative Cognitive Dysfunction).
Since there are differences in the definition and measurement parameters of postoperative cognitive dysfunction, neurophysiological examination is required. However, both preoperative and postoperative cognitive functions can be evaluated with some mini tests. For this purpose, we planned to apply MMST (Mini Mental State Examination) and ACE (Addenbrooke's Cognitive Examination) tests to our patients at certain intervals in our study.
After the approval decision numbered 2024/226 of the Scientific Research Ethics Committee of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital, we trained residents in our clinic to perform MMST and ACE tests. The patients who will undergo sleeve gastrectomy, have been evaluated by the multidisciplinary council for obesity surgery at the General Surgery Clinic of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital and they will be informed about the study by a randomly selected anesthesia resident during the preoperative visit one day before the surgery, and patients verbal and written informed consents will be obtained in accordance with the informed consent forms.
After the consents are taken, a randomly assigned resident will perform MMST and ACE tests on the patients the day before surgery. Patients will be administered inhalational anesthesia or TIVA according to the preference of a random anesthesia specialist physician who is going to work at that day in the operating room of general surgery.
The study will not interfere with the selection of anesthesia method and equal numbers of patients in both groups enrolled. All intraoperative data will be obtained primarily from the hospital information system, medical records and devices, anesthesia follow-up documents, patient follow-up forms and test forms.
The power analysis was performed using the G*Power (v3.1.7) programme to determine the sample size. The power of the study is expressed as 1-β (β =Type II error probability). The effect size was calculated as d=2.954 and it was calculated that in order to obtain 99% power at the α=0.01 level, there should be 20 patients in each group and at least 40 patients in total. Considering that there may be losses during the study process, it was decided to exceed this number and 60 patients were included in the study.
The data will be analyzed using the SPSS 25.0 package program. The Kolmogorov Smirnov test will be used to check whether the distribution of the data is normally distributed, and descriptive statistical methods (Mean, Standard Deviation, Median, IQR, frequency, ratio) will be used when evaluating the study data. Independent t test will be used for two group comparisons showing parametric distribution, and One Way Anova Test analysis methods will be used for more than two group comparisons. Mann-Whitney U test will be used for two group comparisons not showing parametric distribution, and Kruskal Wallis test will be used for more than two group comparisons. Spearman correlation and Pearson correlation analysis will be used to determine the relationship between them. Chi-Square test will be used in the evaluation of categorical data. Significance will be evaluated at p\<0.05 levels for all values.
In a population of patient group who will undergo sleeve gastrectomy as bariatric surgery under general anesthesia in Sancaktepe Sehit Prof. Dr. Ilhan Varank Research and Training Hospital in Istanbul and who have passed the multidisciplinary council for bariatric surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients of both sexes, Patients Aged between 18 and 65 years, Patients classified as ASA() physical status I- III, Patients with a (Body Mass Index) between 35 and 50 kg/m² scheduled to undergo sleeve gastrectomy as a type of bariatric surgery for the first time.
Exclusion Criteria:
Patients classified as 4 or high, Patients with known allergy to any of the drugs used in the study, Patients with bleeding disorders, Patients with serum creatinine levels >2 mg/dL, Patients with severe arrhythmias and EF\<30%, Patients with a known history of drug abuse are excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We planned to visit patients who will undergo sleeve gastrectomy the day before the surgery and perform MMST and ACE tests. All patients will undergo electrocardiogram, pulse oxygen saturation, arterial blood pressure monitoring and bispectral index and near infrared spectroscopy. Induction agents will be used according to ideal body weights, and after intubation, ventilation parameters will be set to ventilation control mode/pressure control mode, taking into account ideal body weights and lung protective mechanical ventilation parameters. All monitoring parameters will be noted. "Total Intravenous Anesthesia" group will receive propofol and remifentanil infusions. Dose adjustments will be made according to hemodynamic parameters, NIRS and BIS values, and the total dose used throghout will be noted. Postoperative eye opening, extubation and recovery times will be noted and both groups are going to be evaluated by postoperative cognitive tests at certain postoperative intervals.
We planned to visit patients who will undergo sleeve gastrectomy the day before the surgery and perform MMST ve ACE tests. All patients will undergo electrocardiogram, pulse oxygen saturation, arterial blood pressure monitoring and bispectral index and near infrared spectroscopy. Induction agents will be used according to ideal body weights, and after intubation, ventilation parameters will be set to ventilation control mode/pressure control mode, taking into account ideal body weights and lung protective mechanical ventilation parameters. All monitoring parameters will be noted. "Inhalational Anesthesia" group will receive sevoflurane and remifentanyl infusion. EtSevo and total remifentanyl doses will be noted as adjusted with hemodynamic parameters, NIRS, BIS values accordingly. In both groups, postoperative eye opening, extubation and recovery times will be noted and both groups are going to be evaluated by applying postoperative cognitive tests at certain postoperative intervals.
detecting postoperative delirium, delayed neurocognitive recovery and POCD (postoperative neurocognitive disorder)
Primary Outcome Measure 1: Time to Eye Opening After Cessation of Anesthetics The time from discontinuation of anesthetic agents to spontaneous eye opening in response to verbal stimulation will be recorded. Time Frame: From cessation of anesthetic agents until eye opening at the end of surgery. Primary Outcome Measure 2: Time to Obey Verbal Commands After Cessation of Anesthetics The time from discontinuation of anesthetic agents until the patient obeys simple verbal commands will be recorded. Time Frame: From cessation of anesthetic agents until obeying verbal commands at the end of surgery. Primary Outcome Measure 3: Time to Extubation The time from discontinuation of anesthetic agents until successful tracheal extubation will be recorded. Time Frame: From cessation of anesthetic agents until extubation at the end of surgery. Primary Outcome Measure 4: Time to Reach Aldrete Recovery Score 9-10 The time required to achieve an Aldrete Recovery Score of 9-10 in the post-anes
Time frame: Mini Mental State Examination(MMSE) Score and Addenbrooke's Cognitive Examination(ACE) Score Preoperative baseline (1 day before surgery), postoperative 1st, 6th, 12th, and 24th hours, postoperative 3rd and 7th days, and postoperative 1st and 3rd months.
Hypertension, hypotension, hypoxia, hypercarbia, brady/tachycardia, VAS (Visual Analogue Scale), nausea and vomiting, bleeding, fever, wound infection, pulmonary complications, length of stay in intensive care unit and hospital.
Any hypertension, hypotension, hypoxia, hypercarbia, brady/tachycardia that may develop during the patient's 1-hour follow-up in the recovery room will be noted, and pain status will be assessed with VAS, nausea-vomiting status and overall patient satisfaction will be assessed. In addition, conditions such as bleeding, fever, wound infection, pulmonary complications that may develop in the patient will be noted, and the length of stay in the intensive care unit and hospital will be recorded.
Time frame: 1 hour in the recovery room.
Plan to share: No — We will not share IPD.
Ran from Sep 2025 to primary completion in Apr 2026, 7 months.
Of 76 non-industry observational studies under Postoperative Cognitive Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's 7 months is below that.
Counting every sponsor, half of 76 studies reached it within 27 months; a quarter within 11 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Postoperative Cognitive Complications →
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital