Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

NCT07611240 | Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/4652025/2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Lumbar Spine Surgery

Keywords

Propofol; Sevoflurane; Pentraxin-3; Serum Amyloid A; Immunomodulation; Total Intravenous Anesthesia; Volatile Anesthesia; Inflammatory Response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Interleukin-6 Level

  Baseline, postoperative 6 hours, and postoperative 24 hours

• Change in Tumor Necrosis Factor-alpha Level

  Baseline, postoperative 6 hours, and postoperative 24 hours

• Change in C-reactive Protein Level

  Baseline, postoperative 6 hours, and postoperative 24 hours

• Change in Blood Glucose Level

  Baseline, postoperative 6 hours, and postoperative 24 hours

Study Arms (2)

Propofol Group

EXPERIMENTAL

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)

Sevoflurane Group

EXPERIMENTAL

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

Interventions

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.

Propofol Group

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.

Sevoflurane Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Hynninen MS, Hurme M, Ala-Kokko TI. Novel biomarkers of sepsis. Ann Med. 2006;38(4):234-242. doi:10.1080/07853890600651816

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21399490 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Ayşe Ceren Hilal Güven, assistant doctor

  Ataturk University Department of Anesthesiology and Reanimation

  STUDY CHAIR

Central Study Contacts

Mehmet Akif Yilmaz, Doctor

CONTACT

+905346533539; mehmetakifyilmaz025@gmail.com

Ayşe Ceren Hilal Güven, assistant doctor

CONTACT

554-112-25-81; achg1995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is single-masked. The anesthesiologist (care provider) administering anesthesia is aware of the group allocation, whereas the laboratory personnel and outcome assessors evaluating the biochemical parameters are blinded to the group assignments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio into two parallel groups receiving either sevoflurane-based inhalational anesthesia or propofol-based total intravenous anesthesia during elective lumbar instrumentation surgery.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 28, 2026
• Study Start: June 15, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

TU (1)