Prospective, Randomized, Simple Blind Study Comparing the Effects of an Anaesthesia With Propofol to an Anaesthesia With Desflurane on Oxydative Stress and Liver Function Recovery After Hepatectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Plasma MDA levels
研究概览
简要总结
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
详细描述
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic hilum during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to ischemic-reperfusion injury, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic hilum clamping.
The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
The evolution over time of other markers of oxidative stress will be studied (glutathione, myeloperoxidase, nitric oxide), as well as functional and biological markers of liver regeneration.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18
- •Need for partial hepatic resection requiring heptic clamping
- •Resection of 4 liver segments or less
- •In case of cirrhosis, child A
- •Written informed consent
- •Non-inclusion Criteria:
- •Hemochromatosis
- •chemotherapy in the previous week before inclusion
- •Thrombosis of the portal vein or the hepatic artery
- •Absence of contraception among fertil woman
- •Concomitant treatment that could have potential interaction with propofol
- •Concomitant treatment known to have antioxidant properties
- •Inclusion in another study protocol using a medication incompatible with the present study
- •Patient in which the follow up seems impossible
排除标准
- 未提供
研究组 & 干预措施
1
Anesthesic induction and maintenance with intravenous propofol.
干预措施: Propofol (Drug)
2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
干预措施: Penthotal (Drug)
2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
干预措施: Desflurane (Drug)
结局指标
主要结局
Plasma MDA levels
时间窗: 30 minutes after the end of hepatic clamping
次要结局
- Surgery related complications(10 days)
- Kinetics of post surgical biological hepatic function recovery(Days 1, 2, 5, 10)
- Kinetics of post surgical hepatic function recovery(Day 2)
- Hemodynamics during and after surgery(Days 1 and 2)
- Other biological markers of oxidative stress(Days 1 and 2)