Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Remifentanil requirement
研究概览
简要总结
This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
详细描述
Justification:
Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and mortality. These patients undergo general anesthesia and often require tight blood pressure control (e.g., using norepinephrine titration) to avoid the complications associated with hypotension and reduced cardiac output. Standard analgesia opioid titration to control nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the anesthesiologist's experience and variations in the patient's heart rate and blood pressure. This causes anesthesiologists to often give too much analgesic, which can lead to inhibition of the sympathetic autonomic nervous system, hypotension, and associated side effects. A recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of measuring the patient's level of nociception-antinociception balance and can guide opioid administration. This monitor may allow anesthesiologists to administer only the required amount of opioid, which may lead to better hemodynamic stability and better postoperative outcome.
Objectives:
The goal of this study is to determine if titrating analgesia using the Nol-Index, when compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine, increased cardiac output, more stable blood pressure control, and decreased postoperative complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-high risk cardiac or vascular surgery
排除标准
- •chronic arrhythmia (e.g. atrial fibrillation)
- •aortic insufficiency
- •pacemaker
- •implanted defibrillator
- •valve surgery
结局指标
主要结局
Remifentanil requirement
时间窗: 2 to 8 hours
µg/kg/hour required during general anesthesia
次要结局
- Mean Blood Pressure(2 to 8 hours)
- Number of patients with 28 day composite and individual adverse outcomes(28 days)
- Heart Rate(2 to 8 hours)
- Systolic Blood Pressure(2 to 8 hours)
- Norepinephrine requirement(2 to 8 hours)
- nicardipine requirement(2 to 8 hours)
- Intraoperative hemodynamic instability(2 to 8 hours)
- esmolol requirement(2 to 8 hours)
- propofol requirement(2 to 8 hours)
- Diastolic Blood Pressure(2 to 8 hours)
- Cardiac Output(2 to 8 hours)
