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

NCT07637357 | Recruiting

• 1 other identifier: Ivstrh- 2024/226
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

POCD - Postoperative Cognitive Dysfunction; Postoperative Delirium; Bariatric Sleeve Gastrectomy; Total Intravenous Anesthesia; Inhalational Anesthesia; Cognitive Functions; Recovery Time; Postoperative Neurocognitive Disorder; Delayed Neurocognitive Recovery

Keywords

total intravenous anesthesia; inhalational anesthesia; sleeve gastrectomy; postoperative cognitive dysfunctions

Outcome Measures

Primary Outcomes (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

  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)

• 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.

  1 hour in the recovery room.

Study Arms (2)

"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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital

Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 33439974 RESULT

• 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.

  PMID: 38590312 RESULT

• 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.

  PMID: 29223575 RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Nuray Turkut

  Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Evin ERGÜN KASAP

CONTACT

+90216-606-33-00; evinergun341694@gmail.com

Nuray Turkut

CONTACT

+90538-583-28-38; drnturkut@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: June 9, 2026
• Study Start: September 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)