NCT01691001已完成不适用
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the reduction rate of ET-sevo in achieving BIS scores from 45-50
研究概览
简要总结
Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA class I
- •obtaining written informed consent from the parents
- •aged 1-5 years, and weighing <20 kg who were undergoing ambulatory hernioplasty or orchiopexy
排除标准
- •mental retardation
- •developmental delays
- •neurological or psychiatric illnesses
- •coagulation disorder
- •spinal anomalies
- •bilateral procedures
研究组 & 干预措施
dexmedetomidine
Experimental
干预措施: Dexmedetomidine (Drug)
placebo group
Placebo Comparator
normal saline
干预措施: normal saline (Drug)
结局指标
主要结局
the reduction rate of ET-sevo in achieving BIS scores from 45-50
时间窗: 2 hour(during whole operation period)
次要结局
未报告次要终点
研究者
研究点 (1)
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