Sevoflurane vs Propofol Anesthesia in Obese Patients Undergoing Lumbar Surgery
2026年5月20日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ayşe Ceren Hilal Güven, assistant doctor
- 电话号码：554-112-25-81
- 邮箱：achg1995@gmail.com
研究联系人备份
- 姓名：Mehmet Akif Yilmaz, Doctor
- 电话号码：+905346533539
- 邮箱：mehmetakifyilmaz025@gmail.com
学习地点
-
-
-
Erzurum、土耳其（türkiye）、25000
- 招聘中
- Ataturk University
-
接触：
- Ayşe Ceren Hilal Güven, assistant doctor
- 电话号码：554-112-25-81
- 邮箱：achg1995@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pentraxin 3 Level
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Interleukin-6 Level
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ayşe Ceren Hilal Güven, assistant doctor、Ataturk University Department of Anesthesiology and Reanimation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年6月15日
初级完成 (估计的)
2026年6月15日
研究完成 (估计的)
2026年6月16日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- B.30.2.ATA.0.01.00/465
- 2025/2 (其他标识符：Atatürk University Clinical Research Ethics Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.