Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery
20 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
70
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ayşe Ceren Hilal Güven, assistant doctor
- Telefoonnummer: 554-112-25-81
- E-mail: achg1995@gmail.com
Studie Contact Back-up
- Naam: Mehmet Akif Yilmaz, Doctor
- Telefoonnummer: +905346533539
- E-mail: mehmetakifyilmaz025@gmail.com
Studie Locaties
-
-
-
Erzurum, Turkije (Türkiye), 25000
- Werving
- Ataturk University
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Contact:
- Ayşe Ceren Hilal Güven, assistant doctor
- Telefoonnummer: 554-112-25-81
- E-mail: achg1995@gmail.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Pentraxin 3 Level
Tijdsspanne: 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.
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Baseline, postoperative 6 hours, and postoperative 24 hours
|
|
Change in Serum Amyloid A Level
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Interleukin-6 Level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, postoperative 6 hours, and postoperative 24 hours
|
C-reactive protein level was measured from blood samples as an inflammatory biomarker.
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Baseline, postoperative 6 hours, and postoperative 24 hours
|
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Change in Blood Glucose Level
Tijdsspanne: Baseline, postoperative 6 hours, and postoperative 24 hours
|
Blood glucose level was measured from blood samples during the perioperative follow-up period.
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Baseline, postoperative 6 hours, and postoperative 24 hours
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009.
- Schilling T, Kozian A, Senturk M, Huth C, Reinhold A, Hedenstierna G, Hachenberg T. Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients. Anesthesiology. 2011 Jul;115(1):65-74. doi: 10.1097/ALN.0b013e318214b9de.
- Garlanda C, Bottazzi B, Bastone A, Mantovani A. Pentraxins at the crossroads between innate immunity, inflammation, matrix deposition, and female fertility. Annu Rev Immunol. 2005;23:337-66. doi: 10.1146/annurev.immunol.23.021704.115756.
- Kramer GC, et al. Monitoring intraoperative urine output: A good indicator of tissue perfusion? Crit Care Clin. 2004;20(2):213-225. doi:10.1016/j.ccc.2004.01.002
- Zoremba N, Dette F, Eberhart LH, Mischkowski D, Sümpelmann R, Graf BM. Bispectral index and entropy for monitoring the hypnotic effects of sevoflurane and propofol. Anesth Analg. 2007;105(6):1721-1727. doi:10.1213/01.ane.0000290546.37250.10
- Inoue S, Tanaka Y, Kawaguchi M. Propofol and volatile anesthetics differently affect systemic inflammatory responses during surgery. Can J Anaesth. 2015;62(5):522-530. doi:10.1007/s12630-015-0345-6
- Helmy SA, Al-Attiyah RJ, El-Touny MA. Immunomodulatory effects of sevoflurane compared to propofol in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2015 Apr-Jun;9(2):170-174. doi:10.4103/1658-354X.152849
- Hynninen MS, Hurme M, Ala-Kokko TI. Novel biomarkers of sepsis. Ann Med. 2006;38(4):234-242. doi:10.1080/07853890600651816
- Uhlar CM, Whitehead AS. Serum amyloid A, the major vertebrate acute-phase reactant. Eur J Biochem. 1999 Oct;265(2):501-23. doi: 10.1046/j.1432-1327.1999.00657.x.
- Draisci G, Aceto P, Vollono C, Zanatta P, Pinto G, Sacco T, Carpenedo R. Anaesthetic strategies in obese patients. Curr Opin Anaesthesiol. 2017 Feb;30(1):117-124. doi:10.1097/ACO.0000000000000419
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 juni 2025
Primaire voltooiing (Geschat)
15 juni 2026
Studie voltooiing (Geschat)
16 juni 2026
Studieregistratiedata
Eerst ingediend
7 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 mei 2026
Eerst geplaatst (Werkelijk)
28 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
20 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Voedingsstoornissen
- Overvoeding
- Lichaamsgewicht
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Overgewicht
- Obesitas
- Organische chemicaliën
- Ethers
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolwaterstoffen, aromatisch
- Fenolen
- Benzeenderivaten
- Koolwaterstoffen, gehalogeneerd
- Koolwaterstoffen, gefluoreerd
- Methylethers
- Sevofluraan
- Propofol
Andere studie-ID-nummers
- B.30.2.ATA.0.01.00/465
- 2025/2 (Andere identificatie: Atatürk University Clinical Research Ethics Committee)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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