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临床试验/NCT00477737
NCT00477737已完成4 期

Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart

University Hospital Dubrava2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年8月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
To evaluate cardiac function with measuring of hemodynamic parameters

研究概览

简要总结

In vitro studies and in vivo animal experiments have shown that halogenated volatile anesthetics have a protective effect on the ischemic myocardium. In clinical settings however, anesthetic preconditioning may be of more interest. The aim of our study was to evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save myocardial function, which we measured acceleration by esophageal Doppler and cardiac index with bolus thermodilution methods, both during brief ischemia and reperfusion.

详细描述

Studies have been performed on human patients undergoing CABG surgery with cardiopulmonary bypass (CPB). Only a few studies however have evaluated the effects of volatile anesthetics during coronary artery bypass grafting on a beating heart (OPCABG) with conflicting results as far as cardiac biomarker release is concerned.

Because CPB is known to have a profound impact on cardiac function, studies performed on patients scheduled for OPCABG could evaluate more specifically the effects of the anesthetic agents themselves. Patients undergoing OPCABG have a predictable and predefined ischemic zone during surgery and represent an extremely interesting and safe model for the study of ischemia and cardiac damage in humans.

Presently, there is still no consensus on the method of administration of volatile anesthetics, including the time to begin administration, its duration, the dosage and selection of volatile anesthetics.

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

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the degree I or II of Cardiac Anesthesia Risk Evaluation score
  • angiographically verified coronary artery disease
  • left ventricular ejection fraction higher than 40%

排除标准

  • atrioventricular conduction disturbances
  • previously ventricular arrhythmias requiring antiarrhythmic treatment
  • atrial fibrillation with rapid ventricular response
  • myocardial infarction or stroke within 6 months
  • diabetes mellitus
  • end-stage of obstructive or restrictive pulmonary disease

结局指标

主要结局

To evaluate cardiac function with measuring of hemodynamic parameters

时间窗: Measurements were performed at the following intervals: 5 minutes after anesthesia induction; at the beginning of ischemia; 15 minutes after ischemia; 15 minutes after sternum closure

次要结局

未报告次要终点

研究者

发起方
University Hospital Dubrava
申办方类型
Other

研究点 (2)

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