Ataturk University
Erzurum, 25000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07611240
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Erzurum, 25000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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-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.
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.
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.
Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours
Interleukin-6 level was measured from blood samples as an inflammatory biomarker.
Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours
Tumor necrosis factor-alpha level was measured from blood samples as an inflammatory biomarker.
Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours
C-reactive protein level was measured from blood samples as an inflammatory biomarker.
Time frame: Baseline, postoperative 6 hours, and postoperative 24 hours
Blood glucose level was measured from blood samples during the perioperative follow-up period.
Contact information is provided by the study sponsor or research team.
Ayşe Ceren Hilal Güven, assistant doctor
CONTACT
Mehmet Akif Yilmaz, Doctor
CONTACT
Ataturk University
Other
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
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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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