NCT04381637已完成不适用
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月28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
- 34
- 试验地点
- 2
- 主要终点
- Variation of NIPE index (∆NIPE)
研究概览
简要总结
NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
- •Written informed consent obtained from parents (and from child if appropriate)
排除标准
- •Thoracic or cardiac surgery
- •Cardiac arrhythmia, Pace maker
- •Analgesic medication less than 24 hours before surgery
- •Chronic anticholinergic medication
- •Contraindication to muscle relaxants or general anesthetics
结局指标
主要结局
Variation of NIPE index (∆NIPE)
时间窗: 3 minutes following tetanic stimulation
∆NIPE = \[NIPE minimal value in the 3 minutes following the stim\] - \[NIPE before stim\] NIPE varies from 0 to 100. Monitor displays one value per second. NIPE index expected to decrease after stim.
次要结局
- Heart rate Variation (∆HR)(3 minutes following tetanic stimulation)
研究者
研究点 (2)
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