- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665645
Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients
Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34899
- Marmara University Faculty of Medicine Pendik Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low-Flow Sevoflurane
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.
|
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.
|
|
Experimental: Normal-Flow Sevoflurane
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.
|
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.
|
|
Experimental: Total Intravenous Anesthesia (TIVA)
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Preoperative, postoperative 30 minutes, and postoperative day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye Opening Time
Time Frame: End of surgery
|
Time from discontinuation of anesthetic administration to spontaneous eye opening
|
End of surgery
|
|
Extubation Time
Time Frame: End of surgery
|
Time from discontinuation of anesthetic administration to tracheal extubation.
|
End of surgery
|
|
Modified Aldrete Recovery Score
Time Frame: Postoperative recovery period
|
Recovery status assessed using the Modified Aldrete Score.
|
Postoperative recovery period
|
|
heart rate
Time Frame: During surgery
|
patient's intraoperative measured heart rate
|
During surgery
|
|
mean arterial pressure
Time Frame: during surgery
|
patient's intraoperative measured mean arterial pressure
|
during surgery
|
|
oxygen saturation
Time Frame: During surgery
|
oxygen saturation of the patient will be recorded
|
During surgery
|
|
end-tidal carbon dioxide
Time Frame: During surgery
|
end-tidal carbon dioxide of the patient will be recorded
|
During surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Tunca, MD, Department of Anesthesiology and Reanimation, Gaziantep City Hospital
- Study Chair: Seniyye Ü Zengin, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
- Study Director: Meliha O Ergün, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Ethers
- Hydrocarbons
- Hydrocarbons, Cyclic
- Acids, Acyclic
- Carboxylic Acids
- Hydrocarbons, Aromatic
- Piperidines
- Phenols
- Benzene Derivatives
- Hydrocarbons, Halogenated
- Hydrocarbons, Fluorinated
- Propionates
- Methyl Ethers
- Remifentanil
- Sevoflurane
- Propofol
Other Study ID Numbers
- MU-09.2022.744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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