Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- incidence of emergence delirium thirty minutes after surgery
研究概览
简要总结
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.
详细描述
There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children undergoing ophthalmologic surgery with general anesthesia
- •children aged 1 - 12 years old
- •physical status ASA 1-2
- •signing informed consent
排除标准
- •children undergoing emergency surgery
- •children with PICU nursing after surgery
- •children with psychological and neurological condition
- •children with allergic history to dexmedetomidine and midazolam
- •children with history of malignant hyperthermia or family history of malignant hyperthermia
- •children with possibility of difficult intubation and ventilation
研究组 & 干预措施
Dexmedetomidine
subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction
干预措施: Intranasal dexmedetomidine (Drug)
Midazolam
subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction
干预措施: Intranasal Midazolam (Drug)
结局指标
主要结局
incidence of emergence delirium thirty minutes after surgery
时间窗: 30 minutes
PAED score was measured
次要结局
未报告次要终点
研究者
Andi Ade Wijaya Ramlan
Principal Investigator, Pediatric Anesthesia Division
Indonesia University