drugset / Trial / NCT07611240
Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery
RandomizedParallel-groupSingle-blindBasic science
Summary
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.
Timeline
- Start
- 2025-06-15
- Primary completion
- 2026-06-15
- Completion
- 2026-06-16
Publications
- Background 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
- Background 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
- Background 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.
- Background 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
- Background 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
- Background Hynninen MS, Hurme M, Ala-Kokko TI. Novel biomarkers of sepsis. Ann Med. 2006;38(4):234-242. doi:10.1080/07853890600651816
- Background 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.
- Background 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.
- Background 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
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propofol | Small molecule | 4 mg/kg | Intravenous |
| Subject | Propofol | Small molecule | 10 mg/kg | Intravenous |
| Subject | Sevoflurane | Other / unclassified | 1 unknown | Inhaled |
| Subject | Sevoflurane | Other / unclassified | 1.3 unknown | Inhaled |