Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07611240

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

Led by Ataturk University · Updated on 2026-05-28

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the immune system effects of sevoflurane-based inhalational anesthesia and propofol-based total intravenous anesthesia in obese adults undergoing elective lumbar instrumentation surgery. Obesity is linked to ongoing low-level inflammation and changes in immune responses, which may affect surgery outcomes. The study will focus on how these two anesthesia methods influence inflammatory markers during the perioperative period in this specific patient group. Seventy patients aged 18 to 65 years with a body mass index between 30 and 34.9 kg/m² will be randomly assigned to receive either propofol-based total intravenous anesthesia or sevoflurane-based inhalational anesthesia during lumbar surgery. Anesthesia induction will be standardized with propofol, remifentanil, and rocuronium. Maintenance will use either propofol infusion (4-10 mg/kg/h) or sevoflurane inhalation (1-1.3 MAC), both combined with remifentanil infusion and monitored by BIS. Blood samples will be taken before surgery, and then at 6 and 24 hours after surgery to assess inflammatory biomarkers. Participants will undergo blood tests to measure levels of Pentraxin-3 and serum amyloid A as primary inflammatory markers, along with secondary markers including IL-6, TNF-alpha, CRP, glucose, and complete blood counts at the three timepoints. The study will monitor these markers to understand how anesthesia type affects immune response. The trial is single-masked, randomized, and conducted at one center, with the overall participation lasting from preoperative screening through the 24-hour postoperative period.

CONDITIONS

Brief Title

Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 65 years
  • Scheduled for elective lumbar instrumentation surgery
  • Body mass index between 30 and 34.9 kg/m²
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants receive either sevoflurane-based inhalational anesthesia or propofol-based total intravenous anesthesia during elective lumbar instrumentation surgery.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 24 hours post-surgery

Participants are monitored with blood sample collections to evaluate inflammatory biomarkers at 6 and 24 hours after surgery.

2 blood sample visits (in-person) at postoperative 6 and 24 hours

Trial Site Locations

Total: 1 location

1

Ataturk University

Erzurum, Turkey (Türkiye), 25000

Actively Recruiting

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Research Team

M

Mehmet Akif Yilmaz, Doctor

A

Ayşe Ceren Hilal Güven, assistant doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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