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Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery

20. maj 2026 opdateret af: Mehmet Akif Yilmaz, Ataturk University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Ayşe Ceren Hilal Güven, assistant doctor
  • Telefonnummer: 554-112-25-81
  • E-mail: achg1995@gmail.com

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
      • Erzurum, Tyrkiet (Türkiye), 25000
        • Rekruttering
        • Ataturk University
        • Kontakt:
          • Ayşe Ceren Hilal Güven, assistant doctor
          • Telefonnummer: 554-112-25-81
          • E-mail: achg1995@gmail.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Propofol Group
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.
Medicin: Propofol (Astra-Zeneca)
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.
Eksperimentel: Sevoflurane Group
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.
Medicin: Sevoflurane
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pentraxin 3 Level
Tidsramme: 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.
Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Serum Amyloid A Level
Tidsramme: Baseline, postoperative 6 hours, and postoperative 24 hours
Serum amyloid A level was measured from blood samples to evaluate the inflammatory response after surgery.
Baseline, postoperative 6 hours, and postoperative 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Interleukin-6 Level
Tidsramme: Baseline, postoperative 6 hours, and postoperative 24 hours
Interleukin-6 level was measured from blood samples as an inflammatory biomarker.
Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Tumor Necrosis Factor-alpha Level
Tidsramme: Baseline, postoperative 6 hours, and postoperative 24 hours
Tumor necrosis factor-alpha level was measured from blood samples as an inflammatory biomarker.
Baseline, postoperative 6 hours, and postoperative 24 hours
Change in C-reactive Protein Level
Tidsramme: Baseline, postoperative 6 hours, and postoperative 24 hours
C-reactive protein level was measured from blood samples as an inflammatory biomarker.
Baseline, postoperative 6 hours, and postoperative 24 hours
Change in Blood Glucose Level
Tidsramme: Baseline, postoperative 6 hours, and postoperative 24 hours
Blood glucose level was measured from blood samples during the perioperative follow-up period.
Baseline, postoperative 6 hours, and postoperative 24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ataturk University

Efterforskere

  • Studiestol: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2025

Primær færdiggørelse (Anslået)

15. juni 2026

Studieafslutning (Anslået)

16. juni 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B.30.2.ATA.0.01.00/465
  • 2025/2 (Anden identifikator: Atatürk University Clinical Research Ethics Committee)

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