Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients

NCT07665645 | Completed

• 1 other identifier: MU-09.2022.744
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Obese patients are at increased risk of postoperative cognitive dysfunction (POCD). The effects of different anesthetic techniques on postoperative cognitive function remain controversial. This prospective randomized study aimed to compare the effects of low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, and total intravenous anesthesia (TIVA) on postoperative cognitive function and recovery characteristics in obese patients undergoing elective laparoscopic abdominal surgery. Cognitive function was assessed using the Mini-Mental State Examination (MMSE) before surgery, at postoperative 30 minutes, and on postoperative day 3.

Conditions

Obesity (BMI>30); Postoperative Cognitive Function

Keywords

Obesity; Cognitive Function; Mini-Mental State Examination; MMSE; Sevoflurane; Total Intravenous Anesthesia; TIVA; Low-Flow Anesthesia; BIS Monitoring; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination (MMSE) Score

  Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).

  Preoperative, postoperative 30 minutes, and postoperative day 3

Secondary Outcomes (7)

• Eye Opening Time

  End of surgery

• Extubation Time

  End of surgery

• Modified Aldrete Recovery Score

  Postoperative recovery period

• heart rate

  During surgery

• mean arterial pressure

  during surgery

Study Arms (3)

Low-Flow Sevoflurane

EXPERIMENTAL

Patients received sevoflurane anesthesia with a fresh gas flow of 1 L/min during maintenance of anesthesia. Anesthetic depth was maintained with BIS values between 40 and 60.

Drug: Sevoflurane (Volatile Anesthetic)

Normal-Flow Sevoflurane

EXPERIMENTAL

Patients received sevoflurane anesthesia with a fresh gas flow of 3 L/min during maintenance of anesthesia. Anesthetic depth was maintained with BIS values between 40 and 60.

Drug: Sevoflurane (Volatile Anesthetic)

Total Intravenous Anesthesia (TIVA)

EXPERIMENTAL

Patients received total intravenous anesthesia with propofol and remifentanil infusion. Anesthetic depth was maintained with BIS values between 40 and 60.

Drug: propofol; Drug: Remifentanil

Interventions

Sevoflurane (Volatile Anesthetic) DRUG

Maintenance of general anesthesia with sevoflurane inhalation. Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.

Low-Flow Sevoflurane; Normal-Flow Sevoflurane

propofol DRUG

Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.

Total Intravenous Anesthesia (TIVA)

Remifentanil DRUG

Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.

Total Intravenous Anesthesia (TIVA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Body mass index (BMI) ≥30 kg/m²
• ASA physical status I-III
• Scheduled for elective laparoscopic abdominal surgery
• Provision of written informed consent

You may not qualify if:

• History of psychiatric disease
• Dementia or known cognitive impairment
• Hearing or language disorders preventing MMSE assessment
• Refusal to participate
• Conversion from laparoscopic to open surgery

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Sevoflurane; Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmet Tunca, MD

  Department of Anesthesiology and Reanimation, Gaziantep City Hospital

  PRINCIPAL INVESTIGATOR

• Seniyye Ü Zengin, MD

  Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital

  STUDY CHAIR

• Meliha O Ergün, MD

  Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were unaware of the anesthetic technique assigned to them. Postoperative cognitive assessments were performed by an outcome assessor blinded to group allocation. Anesthesia providers were aware of treatment allocation because of the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to one of three parallel groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Cognitive function was evaluated using the Mini-Mental State Examination before surgery, at postoperative 30 minutes, and on postoperative day 3.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 24, 2026
• Study Start: January 10, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)