RecruitingNot ApplicableNCT07611240

Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

Comparison of the Immunomodulatory Effects of Sevoflurane and Propofol Anesthesia on Pentraxin-3 and Serum Amyloid A Levels in Obese Patients Undergoing Lumbar Instrumentation Surgery

Sponsor

Ataturk University

Enrollment

70 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity, Overweight Lumbar Spine Surgery

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria16

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

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Interventions

DRUGPropofol (Astra-Zeneca)

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.

DRUGSevoflurane

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.