Fast-track in Cardiac Surgery. Remifentanyl & Sufentanil Anaesthesia for CABG+/-AVR Evaluated by Recovery, Cognitive Dysfunction, Haemodynamics (PAC/TTE) and Cardiac Biochemical Markers (CKMB, TNT, Pro-BNP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cognitive function score
研究概览
简要总结
To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.
详细描述
- Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of opioid given as single drug and in combination with Propofol (first 30 patients only).
- Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30
- Recovery quality and time parameters using objective ICU score criteria
- Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)
排除标准
- •Ejection Fraction < 30%
- •Previous Myocardial Infarction within 4 weeks
- •Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) > 33% of mean arterial pressure (MAP)
- •Arterial hypertension (Sap > 180, Dap > 110)
- •Diabetes, Non- and Insulin dependent
- •Non usable echocardiography windows
研究组 & 干预措施
Remifentanil
Remifentanil the basic opioid drug in anesthesia
干预措施: Remifentanil (Drug)
Sufentanil
Sufentanil the basic opioid drug in anesthesia
干预措施: Sufentanil (Drug)
结局指标
主要结局
Cognitive function score
时间窗: Postoperative day 4
Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients
Fast-track potential
时间窗: Time ((mean hours) to eligible discharge from ICU (up to 48 hours)
Ventilation time and eligible time to discharge based on ICU score
次要结局
- Postoperative cognitive dysfunction(Postoperative day 1 and 30)
- Eligible time to discharge from ICU(Time (hours) to ICD4)
研究者
Carl-Johan Jakobsen
Research Consultant, Ass professor
Aarhus University Hospital