Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
研究概览
简要总结
The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters:
- hemodynamic parameters during and after the operation,
- pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
- release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
- inflammatory response to the operation.
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.
详细描述
General anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium.
After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement.
Hemodynamic parameters will be recorded at the following time points:
- before induction
- after induction
- during trachea intubation
- before skin incision
- 3 Min. after skin incision
- after sternotomy
- before heart positioning for graft placing
- before finishing placing each distal anastomoses
- 10, 20, 30, 40 min after placing the last anastomoses
- 10 Min. after admission to ICU, 6, 12, 18 and 24 hours after surgery.
- TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses.
The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-Wallis/Wilcoxon-U test for categoric or inhomogeneous distributed continuous data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease qualified for CABG off-pump surgery
- •Elective surgery
- •Signed informed consent
排除标准
- •Left ventricle ejection fraction < 30%
- •Serum creatinine > 2 mg/dL
- •Emergency surgery
- •Denied consent
研究组 & 干预措施
1
propofol
干预措施: Diprivan (propofol), Astra-Zeneca (Drug)
2
desflurane
干预措施: Suprane (desflurane), Baxter (Drug)
结局指标
主要结局
Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
时间窗: within the first 2. days after surgery.
次要结局
- Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.(To discharge from hospital (usually within 7 days))