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临床试验/NCT02168751
NCT02168751已完成4 期

STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Change in inflammation markers in plasma and bronchoalveolar lavage

研究概览

简要总结

Lung ventilation required for lung resection surgery induces a proinflammatory response including cytokine production and recruitment of leukocytes and macrophages in the lung associated with postoperative complications, mainly acute lung injury (ALI). The lung-protective ventilation has been shown reduce this inflammatory response and play a protective role against ALI, even though it is unclear the role of intravenous and inhalational anesthetic agents in immunomodulation of the inflammatory response during lung ventilation and its possible protective role against ALI. This study aims to determine the effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative stress and ischemia-reperfusion, and assess the relationship between these mediators and postoperative morbidity defined as percentage of postoperative lung complications (ALI / ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30 days. The investigators hypothesis, based on results of our group in animal research, is that inhalants cause a lower proinflammatory response to intravenous agents for lung resection surgery.

A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung protective ventilation, in which the markers will be measured before and after one-lung ventilation in both lungs and in plasma before, during and after one-lung ventilation. postoperative lung complications, ICU and hospital stay and 30 days mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • candidates to Lung resection surgery at Hospital General Universitario Gregorio Marañón (males and females)
  • willing to participate and sign informed consent
  • age > 18 años and legal capable
  • no urgent surgery.
  • FEV1 >50% or CVF > 50%
  • no previous steroids or immunosuppressors chronic treatment (three months before the surgery)

排除标准

  • pregnancy and breast feeding
  • propofol or sevoflurane hypersensibility.
  • have received blood derivate product within 10 days before surgery.
  • when protective pulmonary ventilation is not possible during one Lung ventilation.
  • Heart failure > II NYHA within one week before surgery

研究组 & 干预措施

propofol

Active Comparator

propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery

干预措施: propofol (Drug)

sevoflurane

Experimental

Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Change in inflammation markers in plasma and bronchoalveolar lavage

时间窗: baseline and 5 minutes

Fiberoptic bronchoalveolar lavage (BAL) performed in both lungs at two moments: Baseline ( 5 minutes before the begining of OLV) and at the end of the OLV ( 5 minutes after the two lung vetilation was restored).

次要结局

未报告次要终点

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Sponsor

研究点 (1)

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