Obesity (BMI>30)NCT07665645
Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients
A study testing Sevoflurane (Volatile Anesthetic), propofol and Remifentanil in people with Obesity (BMI>30) and Postoperative Cognitive Function, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obese patients are at increased risk of postoperative cognitive dysfunction (POCD). The effects of different anesthetic techniques on postoperative cognitive function remain controversial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (BMI>30), Postoperative Cognitive Function
- What is being tested?
- Sevoflurane (Volatile Anesthetic), propofol and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Istanbul, 34899
About this study
Official title: Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
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.
Read the 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.
- Conditions
- Obesity (BMI>30), Postoperative Cognitive Function
- Being tested
- Sevoflurane (Volatile Anesthetic), propofol, Remifentanil
- Keywords
- Obesity, Cognitive Function, Mini-Mental State Examination, MMSE, Sevoflurane, Total Intravenous Anesthesia, TIVA, Low-Flow Anesthesia, BIS Monitoring, Laparoscopic Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
propofolDrug
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
RemifentanilDrug
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE) Score
Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
Measured: Preoperative, postoperative 30 minutes, and postoperative day 3
Secondary outcomes (7)
Eye Opening Time
Time from discontinuation of anesthetic administration to spontaneous eye opening
Measured: End of surgery
Extubation Time
Time from discontinuation of anesthetic administration to tracheal extubation.
Measured: End of surgery
Modified Aldrete Recovery Score
Recovery status assessed using the Modified Aldrete Score.
Measured: Postoperative recovery period
heart rate
patient's intraoperative measured heart rate
Measured: During surgery
mean arterial pressure
patient's intraoperative measured mean arterial pressure
Measured: during surgery
oxygen saturation
oxygen saturation of the patient will be recorded
Measured: During surgery
end-tidal carbon dioxide
end-tidal carbon dioxide of the patient will be recorded
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jan 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmet Tunca, MD, Principal investigator, Department of Anesthesiology and Reanimation, Gaziantep City HospitalSeniyye Ü Zengin, MD, Study chair, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research HospitalMeliha O Ergün, MD, Study director, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665645
- Sponsor's protocol ID
- MU-09.2022.744
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07665645
- Acronym / sponsor ID
- MU-09.2022.744
- Conditions
- Obesity (BMI>30), Postoperative Cognitive Function
- Keywords
- Obesity, Cognitive Function, Mini-Mental State Examination, MMSE, Sevoflurane, Total Intravenous Anesthesia, TIVA, Low-Flow Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-Flow Sevoflurane | Experimental | Drug: Sevoflurane (Volatile Anesthetic)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. |
| Normal-Flow Sevoflurane | Experimental | Drug: Sevoflurane (Volatile Anesthetic)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. |
| Total Intravenous Anesthesia (TIVA) | Experimental | Drug: propofol, Drug: RemifentanilPatients received total intravenous anesthesia with propofol and remifentanil infusion. Anesthetic depth was maintained with BIS values between 40 and 60. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane (Volatile Anesthetic)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. | Drug | Low-Flow Sevoflurane, Normal-Flow Sevoflurane |
| propofolMaintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring. | Drug | Total Intravenous Anesthesia (TIVA) |
| RemifentanilContinuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol. | Drug | Total Intravenous Anesthesia (TIVA) |
Primary outcome
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).
7 secondary outcomes
Eye Opening Time
Time frame: End of surgery
Extubation Time
Time frame: End of surgery
Modified Aldrete Recovery Score
Time frame: Postoperative recovery period
heart rate
Time frame: During surgery
mean arterial pressure
Time frame: during surgery
oxygen saturation
Time frame: During surgery
end-tidal carbon dioxide
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Tunca, MD principal investigator
Department of Anesthesiology and Reanimation, Gaziantep City Hospital
Seniyye Ü Zengin, MD study chair
Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
Meliha O Ergün, MD study director
Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane (Volatile Anesthetic), propofol and Remifentanil in people with Obesity (BMI>30) and Postoperative Cognitive Function, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) Score (time frame: Preoperative, postoperative 30 minutes, and postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.