Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Levels of troponin
研究概览
简要总结
Heart surgery is a considerable source of stress for the myocardium that must be minimized.
Troponin Ic is a reliable marker to determine the level of this myocardial stress.
Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.
The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided informed written consent.
- •Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
- •Anterograde cardioplegia with cold blood
排除标准
- •Adults under guardianship.
- •Patients without national health insurance cover.
- •Epileptics.
- •Heart grafted patients.
- •Patients under 18 years and pregnant or beast-feeding women.
- •Aortic dissections and vascular surgery.
- •Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent
- •Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.
- •pre-operative LVEF<35%.
- •Coronary artery bypass graft alone or associated.
- •Mitral valve replacements.
- •Warm cardioplegia.
研究组 & 干预措施
Sevoflurane Group
干预措施: total anaesthesia and postoperative inhaled sedation with Sevoflurane (Drug)
Propofol Group
干预措施: total intravenous anaesthesia with Propofol. (Drug)
结局指标
主要结局
Levels of troponin
时间窗: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level
次要结局
未报告次要终点