Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Occurrence of at least one postoperative complication
研究概览
简要总结
Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:
- better analgesia and decreased postoperative morphine consumption,
- better respiratory function,
- better hemodynamic stability,
- better postoperative cognitive function.
The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:
- Improved intraoperative hemodynamic stability
- A decrease in the incidence of postoperative complications
- A reduction in intensive care and hospital length of stay
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
- 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
- •Patient who has provided written and informed consent
- •Adult patient
- •Patient undergoing cardiac surgery which is:
- •With bypass surgery
- •Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery
排除标准
- •Person not affiliated to national health insurance
- •Person under legal protection (curatorship, guardianship)
- •Person under court order
- •Pregnant or breastfeeding woman
- •Adult unable to express consent
- •Patient already included once in the study
- •Patient requiring emergency surgery within 24 hours
- •Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used
- •Patients on antidepressants, neuroleptics such as non-selective MAOIs (iproniazid), selective A MAOI (moclobemide), selective B MAOI (selegiline) gabapentin (Neurontin®)
- •Patients with an unprotected atrioventricular conduction disorder
- •Patients with a prolonged QTc (> 450 ms) on preoperative ECG
- •Patient with severe liver failure (PT< 30%)
- •Patient suffering from respiratory failure (Long-term oxygen therapy patient except OSA)
- •Patient with uncontrolled epilepsy
- •Patient with preoperative cognitive dysfunction (MMS <24)
- •Patient with intracranial hypertension
- •Patient with chronic kidney failure (dialysis, creatinine > 200 μmol L-1)
- •Patient with porphyria
- •Patients treated with linezolid (Zyvoxid®)
- •Patients with severe arterial hypotension (systolic BP<90 mmHg)
研究组 & 干预措施
Intervention
干预措施: Balanced general anesthesia without morphine (Drug)
Intervention
干预措施: Data collection (Other)
Intervention
干预措施: Assessment of pain (Other)
Intervention
干预措施: Recovery quality score (Other)
Controle
干预措施: Standard general anesthesia balanced with morphine (Drug)
Controle
干预措施: Data collection (Other)
Controle
干预措施: Assessment of pain (Other)
Controle
干预措施: Recovery quality score (Other)
结局指标
主要结局
Occurrence of at least one postoperative complication
时间窗: 30 days post-surgery
Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death
次要结局
未报告次要终点