Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known allergy to inhalational or intravenous anesthetic agents
Acute or chronic infectious disease
Autoimmune disease or immunodeficiency
Surgery within the last 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Propofol (Astra-Zeneca)
DrugPropofol-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
DrugSevoflurane-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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Propofol GroupExperimental treatment 1 intervention
Group B: Sevoflurane GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pentraxin 3 Level
Pentraxin 3 level was measured from blood samples to evaluate the immunomodulatory effects of propofol- and sevoflurane-based anesthesia.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hours2
Change in Serum Amyloid A Level
Serum amyloid A level was measured from blood samples to evaluate the inflammatory response after surgery.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hoursSecondary outcomes
1
Change in Interleukin-6 Level
Interleukin-6 level was measured from blood samples as an inflammatory biomarker.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hours2
Change in Tumor Necrosis Factor-alpha Level
Tumor necrosis factor-alpha level was measured from blood samples as an inflammatory biomarker.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hours3
Change in C-reactive Protein Level
C-reactive protein level was measured from blood samples as an inflammatory biomarker.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hours4
Change in Blood Glucose Level
Blood glucose level was measured from blood samples during the perioperative follow-up period.
Time frame
Baseline, postoperative 6 hours, and postoperative 24 hoursSponsors and contacts
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Source ClinicalTrials.gov