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POCD - Postoperative Cognitive DysfunctionNCT07637357

The Effects of Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy

An observational study of POCD - Postoperative Cognitive Dysfunction and Recovery Time, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2025to 30 Jul 2026
How long will I take part?
3 Months
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Patients of both sexes, Patients Aged between 18 and 65 years, Patients classified as ASA(American Society of Anesthesiologists) physical status I- III, Patients with a BMI (Body Mass Index) between 35 and 50 kg/m² scheduled to undergo sleeve gastrectomy as a type of bariatric surgery for the first time.

Who cannot join

  • Patients classified as ASA physical status 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital

    Istanbul, Sancaktepe, 34785

    Evin ERGÜN KASAP, +90216 606 33 00, evinergun341694@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Total Intravenous Anesthesia and Inhalational Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy

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.

Read more

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.

Read the detailed description

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.

Keywords
total intravenous anesthesia, inhalational anesthesia, sleeve gastrectomy, postoperative cognitive dysfunctions
Medical subject headings
Postoperative Cognitive Complications, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07637357
Study groupRoleWhat they receive
"Total Intravenous Anesthesia"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.
"Inhalational Anesthesia"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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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.

Secondary outcomes (1)
  1. 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.

    Measured: 1 hour in the recovery room.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start30 Sep 2025
  3. Primary completion30 Apr 2026
  4. Study completion30 Jul 2026 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637357
Sponsor's protocol ID
Ivstrh- 2024/226
Status last verified
Jun 2025
First submitted
28 Aug 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will not share IPD.

Publications

  • Li Y, Chen D, Wang H, Wang Z, Song F, Li H, Ling L, Shen Z, Hu C, Peng J, Li W, Xing W, Pan J, Liang H, Zhou Q, Cai J, He Z, Peng S, Zeng W, Zuo Z. Intravenous versus Volatile Anesthetic Effects on Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery. Anesthesiology. 2021 Mar 1;134(3):381-394. doi: 10.1097/ALN.0000000000003680.

    PubMed 33439974
  • Song T, Wu LJ, Li L. Comparison of combined intravenous and inhalation anesthesia and total intravenous anesthesia in laparoscopic surgery and the identification of predictive factors influencing the delayed recovery of neurocognitive function. Front Med (Lausanne). 2024 Mar 25;11:1353502. doi: 10.3389/fmed.2024.1353502. eCollection 2024.

    PubMed 38590312
  • Elbakry AE, Sultan WE, Ibrahim E. A comparison between inhalational (Desflurane) and total intravenous anaesthesia (Propofol and dexmedetomidine) in improving postoperative recovery for morbidly obese patients undergoing laparoscopic sleeve gastrectomy: A double-blinded randomised controlled trial. J Clin Anesth. 2018 Mar;45:6-11. doi: 10.1016/j.jclinane.2017.12.001. Epub 2017 Dec 8.

    PubMed 29223575

Questions about this trial

What is this clinical trial studying?

An observational study of POCD - Postoperative Cognitive Dysfunction and Recovery Time, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Jun 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?

Contact Evin ERGÜN KASAP (+90216-606-33-00 ext. +905369911942, evinergun341694@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

detecting postoperative delirium, delayed neurocognitive recovery and POCD (postoperative neurocognitive disorder) (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.). 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 NCT07637357, 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 9 Jun 2026.

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