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临床试验/NCT04137991
NCT04137991已完成不适用

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年10月10日最近更新:
适应症

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

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)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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