NCT04432480已完成不适用
Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年6月23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
- 90
- 试验地点
- 1
- 主要终点
- Variation of the instantaneous NIPE index after opioid administration
研究概览
简要总结
Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery under general anesthesia
- •Absence of analgesic treatment in the 24 hours before the intervention
排除标准
- •Central or peripheral neuropathy
- •Non sinus arrythmia, pace maker
- •Cardiac surgery
- •Analgesic medication within 24 hours before surgery
- •Anti cholinergic or anti arrythmic chronic medication
- •Opposition of the legal tutor or of the child
结局指标
主要结局
Variation of the instantaneous NIPE index after opioid administration
时间窗: 5 minutes after opioid administration
次要结局
- Variation of the instantaneous NIPE index after skin incision(5 minutes after skin incision)
- the area under the ROC curve of NIPE value(Baseline and 5 minutes before the first hemodynamic event.)
- Variation of the instantaneous NIPE index after removal of airway control device(5 minutes after removal of airway control device)
- Variation of the instantaneous NIPE index after insertion of airway control device(5 minutes after insertion of airway control device)
- Variation of the instantaneous NIPE index after anesthetic induction(5 minutes after anesthetic induction)
研究者
研究点 (1)
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