Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025/2 | Other Identifier | Atatürk University Clinical Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol Group | Experimental | 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. |
|
| Sevoflurane Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol (Astra-Zeneca) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pentraxin 3 Level | 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 | Serum amyloid A level was measured from blood samples to evaluate the inflammatory response after surgery. | Baseline, postoperative 6 hours, and postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-6 Level | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Akif Yilmaz, Doctor | Contact | +905346533539 | mehmetakifyilmaz025@gmail.com | |
| Ayşe Ceren Hilal Güven, assistant doctor | Contact | 554-112-25-81 | achg1995@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayşe Ceren Hilal Güven, assistant doctor | Ataturk University Department of Anesthesiology and Reanimation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Recruiting | Erzurum | 25000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 | ||
| 15809132 | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Participants will be randomized in a 1:1 ratio into two parallel groups receiving either sevoflurane-based inhalational anesthesia or propofol-based total intravenous anesthesia during elective lumbar instrumentation surgery.
Not provided
Not provided
The study is single-masked. The anesthesiologist (care provider) administering anesthesia is aware of the group allocation, whereas the laboratory personnel and outcome assessors evaluating the biochemical parameters are blinded to the group assignments.
| Sevoflurane | Drug | 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. |
|
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 | 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 | Blood glucose level was measured from blood samples during the perioperative follow-up period. | Baseline, postoperative 6 hours, and postoperative 24 hours |
| 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 |
| 10504381 | 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. |
| 15771574 | 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 |
| 21399490 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |