Clinical trial

Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT07611240

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Lumbar Spine Surgery

Full registry criteria

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

Treatments and study arms

Propofol (Astra-Zeneca)

Drug

Propofol-based total intravenous anesthesia (TIVA) administered via continuous infusion (4-10 mg/kg/h) in combination with remifentanil for maintenance of anesthesia under BIS monitoring during elective lumbar instrumentation surgery.

Sevoflurane

Drug

Sevoflurane-based inhalational anesthesia administered at 1-1.3 MAC in combination with remifentanil infusion for maintenance of anesthesia under BIS monitoring during elective lumbar instrumentation surgery.

Primary outcomes

Change in Pentraxin 3 LevelBaseline, postoperative 6 hours, and postoperative 24 hours

Pentraxin 3 level was measured from blood samples to evaluate the immunomodulatory effects of propofol- and sevoflurane-based anesthesia.

Change in Serum Amyloid A LevelBaseline, postoperative 6 hours, and postoperative 24 hours

Serum amyloid A level was measured from blood samples to evaluate the inflammatory response after surgery.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ataturk University🌐 Erzurum, Turkey (Türkiye)

Open map

Ayşe Ceren Hilal Güven, assistant doctorContact

Email · Call 554-112-25-81