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临床试验/NCT03816592
NCT03816592已完成不适用

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Complications

研究概览

简要总结

Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • cardiac surgery with cardiopulmonary bypass

排除标准

  • patient with chronic analgesia treatment
  • patient on antidepressive therapy
  • gabapentin use
  • preoperative cognitive dysfunction
  • patient treated with zyvoxid

研究组 & 干预措施

Opioid free anaesthesia

patient anesthtesized with lidocaine, ketamine and dexamethasone

干预措施: Opioid free anaesthesia (Procedure)

Opioid anaesthesia

patients anesthetized with sufentanil ketamine and dexamethasone

干预措施: Opioid anaesthesia (Procedure)

结局指标

主要结局

Complications

时间窗: Day 7

composite end point of post operative complications (cardiac, neurological, renal, respiratory)

Morphine consumption

时间窗: Day 2

Total morphine consumption over the first 48 post operative hours in milligrammes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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