NCT05672212招募中不适用
Effect of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) During General Anesthesia in Children Undergoing EDAS (Encephaloduroarteriosynangiosis) Surgery for Moyamoya Disease: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the mean hourly intraoperative sufentanil requirement
研究概览
简要总结
Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients receiving EDAS surgery for Moyamoya disease
排除标准
- •ASA (American society of anesthsiologists classification) 4-5
- •Emergency surgery
- •patients with chronic pain on medication
研究组 & 干预措施
ANI (Analgesia/Nociception Index) monitoring
Experimental
干预措施: ANI (Analgesia/Nociception Index) monitoring (Device)
ANI (Analgesia/Nociception Index) monitoring
Experimental
干预措施: Sufentanil (Drug)
Standard monitoring
Active Comparator
干预措施: standard monitoring (Device)
Standard monitoring
Active Comparator
干预措施: Sufentanil (Drug)
结局指标
主要结局
the mean hourly intraoperative sufentanil requirement
时间窗: from induction of anesthesia to end of operation, about 5 hours
次要结局
- the amount of non-opioids analgesic requirements(from induction of anesthesia to end of operation, about 5 hours)
- the amount of vasoactive agents requirements(from induction of anesthesia to end of operation, about 5 hours)
研究者
Eun-hee Kim
professor
Seoul National University Hospital
研究点 (1)
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