Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
研究概览
简要总结
The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-12 years
- •Elective surgery under general anesthesia
- •Written informed consent
排除标准
- •Cardiac surgery
- •Opioid intake < 24 hours before surgery
- •Cardiac arrhythmia
- •Pace maker
- •Pheochromocytoma
- •Anti-arrhythmic medication
- •Anticholinergic medication
- •Raynaud syndrome
- •Digital anomaly (malformative, traumatic)
结局指标
主要结局
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
时间窗: 5 minutes after stimulation
NoL variation = \[(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)\] / \[NoL before stimulation\]
次要结局
- Systolic Blood Pressure (SBP) variation(5 minutes after stimulation)
- Analgesia Nociception Index (ANI) variation(5 minutes after stimulation)