NCT03749304已完成不适用
Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年3月16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
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change of ANI greater than 20 points
研究概览
简要总结
The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 with IBD
- •Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion
排除标准
- •patient included in another current study or the previous month
- •urgent surgery
- •toxicomania or receiving opioids preoperatively
- •pregnant woman
- •psychosis
- •betablocker treatment
- •diabetic dysautonomia
- •non-sinus heart rate
- •pacemaker heart transplant
研究组 & 干预措施
ANI monitor
Experimental
干预措施: ANI monitor (Device)
结局指标
主要结局
Change of ANI greater than 20 points
时间窗: During the surgery, an average Three hours and a half
ANI decrease greater than 20 points between a "NoStim" period before surgical incision under general anesthesia and a period of intraoperative "ReactHemo" hemodynamic reactivity defined by a 20% increase in FC and / or PAS.
次要结局
未报告次要终点
研究者
研究点 (1)
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