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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spine Surgery; Obesity & Overweight
• Intervention / Treatment: Drug: Propofol (Astra-Zeneca); Drug: Sevoflurane

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Ceren Hilal Güven, assistant doctor; Phone Number: 554-112-25-81; Email: achg1995@gmail.com
• Study Contact Backup: Name: Mehmet Akif Yilmaz, Doctor; Phone Number: +905346533539; Email: mehmetakifyilmaz025@gmail.com

Study Locations

• Turkey (Türkiye)
  • Erzurum, Turkey (Türkiye), 25000
    • Recruiting
    • Ataturk University
    • Contact: Ayşe Ceren Hilal Güven, assistant doctor; Phone Number: 554-112-25-81; Email: achg1995@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol Group; Patients in this group will receive propofol-based total intravenous anesthesia (TIVA) during elective lumbar instrumentation surgery. Anesthesia will be maintained with propofol infusion (4-10 mg/kg/h) combined with remifentanil infusion under BIS monitoring.	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.
Experimental: Sevoflurane Group; Patients in this group will receive sevoflurane-based inhalational anesthesia during elective lumbar instrumentation surgery. Anesthesia will be maintained with sevoflurane (1-1.3 MAC) combined with remifentanil infusion under BIS monitoring.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pentraxin 3 Level	Pentraxin 3 level was measured from blood samples to evaluate the immunomodulatory effects of propofol- and sevoflurane-based anesthesia.	Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Serum Amyloid A Level	Serum amyloid A level was measured from blood samples to evaluate the inflammatory response after surgery.	Baseline, postoperative 6 hours, and postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interleukin-6 Level	Interleukin-6 level was measured from blood samples as an inflammatory biomarker.	Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Tumor Necrosis Factor-alpha Level	Tumor necrosis factor-alpha level was measured from blood samples as an inflammatory biomarker.	Baseline, postoperative 6 hours, and postoperative 24 hours
Change in C-reactive Protein Level	C-reactive protein level was measured from blood samples as an inflammatory biomarker.	Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Blood Glucose Level	Blood glucose level was measured from blood samples during the perioperative follow-up period.	Baseline, postoperative 6 hours, and postoperative 24 hours

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Chair: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• 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.
• Schilling T, Kozian A, Senturk M, Huth C, Reinhold A, Hedenstierna G, Hachenberg T. Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients. Anesthesiology. 2011 Jul;115(1):65-74. doi: 10.1097/ALN.0b013e318214b9de.
• 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.
• 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
• 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.
• Draisci G, Aceto P, Vollono C, Zanatta P, Pinto G, Sacco T, Carpenedo R. Anaesthetic strategies in obese patients. Curr Opin Anaesthesiol. 2017 Feb;30(1):117-124. doi:10.1097/ACO.0000000000000419

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 16, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; Immunomodulation; Inflammatory Response; Total Intravenous Anesthesia; Serum Amyloid A; Pentraxin-3; Volatile Anesthesia
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Sevoflurane; Propofol
• Other Study ID Numbers: B.30.2.ATA.0.01.00/465; 2025/2 (Other Identifier: Atatürk University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No