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Completed

NCT Number: NCT07665645

Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

About this study

Obesity is associated with physiological alterations that may increase the risk of postoperative cognitive dysfunction (POCD). The influence of anesthetic techniques on postoperative cognitive outcomes in obese patients remains uncertain.

This prospective randomized study was conducted in obese patients (BMI ≥30 kg/m²) aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients were randomly assigned to one of three groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Anesthetic depth was monitored using bispectral index (BIS) monitoring and maintained between 40 and 60 in all groups.

The primary objective was to compare postoperative cognitive function among the three anesthetic techniques using the Mini-Mental State Examination (MMSE). MMSE scores were evaluated preoperatively, at postoperative 30 minutes, and on postoperative day 3.

Secondary objectives included comparison of recovery characteristics, including eye-opening time, extubation time, Modified Aldrete Recovery Scores, and perioperative hemodynamic parameters.

The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2022.744) and written informed consent was obtained from all participants before enrollment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Propofol

Drug

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

Remifentanil

Drug

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

Primary outcomes

  1. Mini-Mental State Examination (MMSE) Score

    Time frame: Preoperative, postoperative 30 minutes, and postoperative day 3

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

Secondary outcomes

  1. Eye Opening Time

    Time frame: End of surgery

    Time from discontinuation of anesthetic administration to spontaneous eye opening

  2. Extubation Time

    Time frame: End of surgery

    Time from discontinuation of anesthetic administration to tracheal extubation.

  3. Modified Aldrete Recovery Score

    Time frame: Postoperative recovery period

    Recovery status assessed using the Modified Aldrete Score.

  4. heart rate

    Time frame: During surgery

    patient's intraoperative measured heart rate

  5. mean arterial pressure

    Time frame: during surgery

    patient's intraoperative measured mean arterial pressure

  6. oxygen saturation

    Time frame: During surgery

    oxygen saturation of the patient will be recorded

  7. end-tidal carbon dioxide

    Time frame: During surgery

    end-tidal carbon dioxide of the patient will be recorded

Sponsors and collaborators

Lead sponsor

Gaziantep City Hospital

Other

Registry information

Official study title

Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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