Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Malondialdehyde level
研究概览
简要总结
Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been informed, the affirmative agreement has been obtained and inclusion and exclusion criteria verified the patients are randomized to 30% or 60% oxygen concentration. In the operating room while placing the intravenous line, a sample blood is obtained. General anesthesia is induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in order to provide the oxygen concentration according to the randomization. One hour later a second venous sample is obtained. Samples are stored in cold conditions until their analysis in the laboratories of the biology faculty - Barcelona University.
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
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective surgery, under general anesthesia.
- •ASA 1 - 2
- •Orl surgery, reconstructive surgery, neck surgery, abdominal wall surgery.
排除标准
- •Smoking Habit
- •Pregnancy
- •No compensated disease.
- •ASA 3 or Higher.
研究组 & 干预措施
Oxygen 30%
Patient receives 1 hour of general anesthesia with a 30% oxygen concentration.
干预措施: 30% of oxygen concentration. (Drug)
Oxygen 60%
Patient receives 1 hour of general anesthesia with a 60% oxygen concentration.
干预措施: 60% of oxygen concentration. (Drug)
结局指标
主要结局
Change in Malondialdehyde level
时间窗: Baseline and after one hour of general anesthesia
A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.
次要结局
- Change in proteic oxidation level(Baseline and after one hour of general anesthesia.)
- Change in glutathion level(Baseline and after one hour of general anesthesia.)