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临床试验/NCT02916147
NCT02916147Unknown不适用

Comparison of Volatile and IV Anesthesia on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy

Tianjin Medical University Cancer Institute and Hospital0 个研究点目标入组 40 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
Change of level of HMGN1

研究概览

简要总结

This study aim to observe and compare the change of alarmins such as high mobility group nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect of inhalational and intravenous anesthesia on the prognosis of surgical patients.

详细描述

During pulmonary lobectomy, as a result of OLV and surgical operation, patients can suffer from alveolar and systemic inflammatory response. Alarmin is endogenous peptide released by white blood cells and epithelial cells when the body undergo danger signal stimulation which can enhance immune response and has a double effect on tumor. Some alarmins and their soluble receptors such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 can be used as biomarkers for tumor progression. Previous studies have shown that sevoflurane anesthesia can reduce the level of inflammatory cytokines in bronchoalveolar lavage fluid. Meanwhile, the latest retrospective study indicated that the mortality of cancer patients receiving volatile anesthesia was significantly higher than that of intravenous anesthesia. At this stage, no study aimed to investigate the change of alarmins in broncho-alveoli and serum during OLV lung surgery and the possible effect of different anesthetics on them. Therefore, the investigators plan to enroll 40 patients with lung cancer receiving pulmonary lobectomy. Patients are randomly divided into sevoflurane volatile anesthesia group and propofol intravenous anesthesia group (n=20). Perioperative serum and bronchoalveolar lavage from ventilated lung are obtained, using ELISA method, to assay and compare the changes of alarmins such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 between two groups. All the patients will be followed up for 12 months. The correlation of alarmins and prognosis as well as the effect of volatile and intravenous anesthesia on the prognosis of patients will be preliminarily evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American society of Anesthesiology (ASA) status I-II
  • pathological diagnosis of lung cancer before surgery
  • receive pulmonary lobectomy
  • with normal lung function
  • without heart failure (NYHA>2), obstructive or restrictive lung disease
  • no history of other malignancy tumor
  • body mass index (Body mass, index, BMI) < 35kg/m2
  • no severe coagulopathy
  • no severe systemic or pulmonary infection
  • did not participate in other clinical trials

排除标准

  • persistent smoking history
  • immunosuppressive drug use 6 weeks before operation
  • receive total pneumonectomy
  • failure to complete treatment or follow-up
  • severe adverse drug reactions
  • severe postoperative complications

研究组 & 干预措施

intravenous anesthesia

Active Comparator

Anesthesia was maintained by a continuous infusion of propofol (4-6mg/kg/h)with BIS 40-60.

干预措施: Propofol (Drug)

volatile anesthesia

Experimental

Use 2-3% sevoflurane to maintain the anesthesia during OLV surgery with bispectral index (BIS) 40-60.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Change of level of HMGN1

时间窗: 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

Change of level of HMGb1

时间窗: 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

Change of level of sTLR4

时间窗: 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

Change of level of IL-33

时间窗: 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

Change of level of sST2

时间窗: 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery

次要结局

  • Disease-free survival(12 months)
  • Overall survival(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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