Evaluation of Total (Pre and Post) Conditioning on Rhabdomyolysis of Sedation With Sevoflurane Versus Propofol in Vascular Surgery With Clamping
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- change from baseline Creatine PhosphoKinase
研究概览
简要总结
Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today.
In humans, the protective effects of halogenated agents have principally been studied in heart surgery and have shown encouraging clinical results. It seems that HAA induce both pre-conditioning of the myocardium (early and late) and post conditioning.
Given these protective effects of HAA, in 2007, the American Heart Association (AHA) recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients with a high cardio-vascular risk. The aim of this study is to show a decrease in rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane anaesthesia, in the post-operative period following vascular surgery with clamping
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •persons who have provided written consent
- •patients over 18 years of age
- •patients undergoing scheduled vascular surgery with high clamping for:
- •Abdominal aortic aneurysm
- •suprapopliteal vascular bypass (aorto-bi-femoral, femoral trifurcation, ilio-femoral or femoro-femoral, femoro-popliteal).
排除标准
- •persons without health insurance cover
- •patients younger than 18 years of age, pregnant or breast-feeding women and adults under guardianship
- •patients with epilepsy
- •emergency surgery
- •patient presenting a contra-indication for Sevoflurane: hypersensitivity to sevoflurane or to other halogenated anaesthetic agents, myopathy, hyper-eosinophilia, immunoallergic hepatitis, known or suspected genetic predisposition to malignant hyperthermia
- •patients presenting a contra-indication to the use of Propofol: known hypersensitivity to propofol or to one of the constituents of the product, allergy to peanuts or soja
- •Patients presenting a contra-indication for sufentanil: hypersensitivity to sufentanil or to opioids
- •Association with opioid agonists-antagonists or partial opioid antagonists
- •patients presenting a CI for the use of Cisatracurium: history of allergy or hypersensitivity to cisatracurium or atracurium
- •patients presenting cardiac, respiratory, renal or kidney failure, hypovolemia, poor general health
- •Patients with a risl of prolongation of the QT interval
- •Patients with end-stage renal failure - requiring dialysis
研究组 & 干预措施
propofol
干预措施: maintenance of anaesthesia with propofol (Drug)
sevoflurane
干预措施: maintenance of anaesthesia with sevoflurane (Drug)
结局指标
主要结局
change from baseline Creatine PhosphoKinase
时间窗: up to 24 hours post surgery
次要结局
未报告次要终点