Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, 34899, Turkey (Türkiye)
NCT Number: NCT07665645
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, 34899, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.
Time frame: Preoperative, postoperative 30 minutes, and postoperative day 3
Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
Time frame: End of surgery
Time from discontinuation of anesthetic administration to spontaneous eye opening
Time frame: End of surgery
Time from discontinuation of anesthetic administration to tracheal extubation.
Time frame: Postoperative recovery period
Recovery status assessed using the Modified Aldrete Score.
Time frame: During surgery
patient's intraoperative measured heart rate
Time frame: during surgery
patient's intraoperative measured mean arterial pressure
Time frame: During surgery
oxygen saturation of the patient will be recorded
Time frame: During surgery
end-tidal carbon dioxide of the patient will be recorded
Gaziantep City Hospital
Other
Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
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.
Published trials that share one or more normalized conditions with this study.
NCT07678944
Body Weight, Cardiovascular Diseases
Coimbra, Coimbra District, Portugal
View Trial DetailsNCT07658261
Body Weight, Nutrition Disorders
Tehran, Tehran Province, Iran
View Trial DetailsNCT07603141
Behavior, Behavior, Animal
Trikala, Greece
View Trial DetailsNCT07653464
Body Weight, Glucose Metabolism Disorders
Columbia, Missouri, United States
View Trial Details