Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery (NCT07611240) | Clinical Trial Compass
RecruitingNot Applicable
Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery
Turkey (Türkiye)70 participantsStarted 2025-06-15
Plain-language summary
This randomized, single-center, single-masked clinical trial aims to compare the immunomodulatory effects of sevoflurane-based inhalational anesthesia and propofol-based total intravenous anesthesia in obese patients undergoing elective lumbar instrumentation surgery. Seventy patients will be randomized into two groups: a propofol group and a sevoflurane group. Blood samples will be collected preoperatively, at postoperative 6 hours, and at postoperative 24 hours. Pentraxin-3 and serum amyloid A levels will be evaluated as primary inflammatory biomarkers together with IL-6, TNF-α, CRP, glucose, and complete blood count parameters.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 18 and 65 years
* Patients scheduled for elective lumbar instrumentation surgery
* Body mass index between 30 and 34.9 kg/m²
* Patients who provided written informed consent
Exclusion Criteria:
* Known allergy to inhalational or intravenous anesthetic agents
* Acute or chronic infectious disease
* Autoimmune disease or immunodeficiency
* Surgery within the last 3 months
* Chronic anti-inflammatory or immunomodulatory drug use
* Morbid obesity, defined as BMI \>35 kg/m²
* History of malignancy or active cancer treatment
* Renal failure, defined as GFR \<60 mL/min
* Liver failure, defined as AST or ALT greater than 2 times the upper limit of normal
* Diabetes mellitus, metabolic syndrome, or insulin resistance
* Pregnancy or lactation
* Neurological disease, including epilepsy, multiple sclerosis, or Parkinson's disease
* Alcohol or substance abuse
* Inability to comply with the study protocol or provide informed consent
* Known allergy to study drugs (propofol, sevoflurane, remifentanil)
* Emergency surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pentraxin 3 Level
Timeframe: Baseline, postoperative 6 hours, and postoperative 24 hours
2
Change in Serum Amyloid A Level
Timeframe: Baseline, postoperative 6 hours, and postoperative 24 hours