Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

Official title

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

Overview

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.

Detailed description

Obesity is associated with chronic low-grade inflammation and altered immune responses, which may influence perioperative outcomes. Different anesthetic techniques may modulate inflammatory and immunological pathways during the perioperative period. However, the comparative immunomodulatory effects of inhalational and intravenous anesthetic techniques in obese patients undergoing lumbar instrumentation surgery remain insufficiently investigated.

This prospective, randomized, single-center, single-masked clinical trial is designed to evaluate the effects of sevoflurane-based inhalational anesthesia and propofol-based total intravenous anesthesia on perioperative inflammatory biomarkers in obese patients undergoing elective lumbar instrumentation surgery.

A total of 70 patients aged 18-65 years with a body mass index between 30 and 34.9 kg/m² will be enrolled and randomized in a 1:1 ratio into two study groups. In both groups, anesthesia induction will be standardized using propofol, remifentanil, and rocuronium. Maintenance anesthesia will be performed with either sevoflurane inhalation or propofol infusion in combination with remifentanil infusion under BIS monitoring.

Blood samples will be collected at three different time points: preoperatively, postoperative 6th hour, and postoperative 24th hour. Pentraxin-3 and serum amyloid A levels will be evaluated as the primary inflammatory biomarkers. Secondary laboratory parameters will include IL-6, TNF-α, CRP, glucose, and complete blood count values.

The findings of this study may contribute to understanding the immunomodulatory effects of commonly used anesthetic techniques and may help optimize perioperative anesthetic management in obese patients undergoing spinal surgery.

Interventions

• Drug Propofol (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.
• Drug Sevoflurane
  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 outcome measures

• Change in Pentraxin 3 Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]
• Change in Serum Amyloid A Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]

Secondary outcome measures (4)

• Change in Interleukin-6 Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]
• Change in Tumor Necrosis Factor-alpha Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]
• Change in C-reactive Protein Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]
• Change in Blood Glucose Level [Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

Turkey (Türkiye) · 1 center

• Ataturk University — Erzurum

Publications

• Kramer GC, et al. Monitoring intraoperative urine output: A good indicator of tissue perfusion? Crit Care Clin. 2004;20(2):213-225. doi:10.1016/j.ccc.2004.01.002
• Zoremba N, Dette F, Eberhart LH, Mischkowski D, Sümpelmann R, Graf BM. Bispectral index and entropy for monitoring the hypnotic effects of sevoflurane and propofol. Anesth Analg. 2007;105(6):1721-1727. doi:10.1213/01.ane.0000290546.37250.10
• Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009. PMID 15809132
• Inoue S, Tanaka Y, Kawaguchi M. Propofol and volatile anesthetics differently affect systemic inflammatory responses during surgery. Can J Anaesth. 2015;62(5):522-530. doi:10.1007/s12630-015-0345-6
• Helmy SA, Al-Attiyah RJ, El-Touny MA. Immunomodulatory effects of sevoflurane compared to propofol in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2015 Apr-Jun;9(2):170-174. doi:10.4103/1658-354X.152849
• Hynninen MS, Hurme M, Ala-Kokko TI. Novel biomarkers of sepsis. Ann Med. 2006;38(4):234-242. doi:10.1080/07853890600651816
• Uhlar CM, Whitehead AS. Serum amyloid A, the major vertebrate acute-phase reactant. Eur J Biochem. 1999 Oct;265(2):501-23. doi: 10.1046/j.1432-1327.1999.00657.x. PMID 10504381
• Garlanda C, Bottazzi B, Bastone A, Mantovani A. Pentraxins at the crossroads between innate immunity, inflammation, matrix deposition, and female fertility. Annu Rev Immunol. 2005;23:337-66. doi: 10.1146/annurev.immunol.23.021704.115756. PMID 15771574

Identifiers

NCT: NCT07611240 · B.30.2.ATA.0.01.00/465 · 2025/2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗