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NCT Number: NCT07611240

Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Ceren Hilal Güven, assistant doctor

CONTACT

[email protected]

554-112-25-81

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in Pentraxin 3 Level

    Time frame: Baseline, 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.

  2. Change in Serum Amyloid A Level

    Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours

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

Secondary outcomes

  1. Change in Interleukin-6 Level

    Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours

    Interleukin-6 level was measured from blood samples as an inflammatory biomarker.

  2. Change in Tumor Necrosis Factor-alpha Level

    Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours

    Tumor necrosis factor-alpha level was measured from blood samples as an inflammatory biomarker.

  3. Change in C-reactive Protein Level

    Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours

    C-reactive protein level was measured from blood samples as an inflammatory biomarker.

  4. Change in Blood Glucose Level

    Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours

    Blood glucose level was measured from blood samples during the perioperative follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Ceren Hilal Güven, assistant doctor

CONTACT

[email protected]

554-112-25-81

Mehmet Akif Yilmaz, Doctor

CONTACT

[email protected]

+905346533539

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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