Comparison of midazolam with propofol given at the end of surgery for prevention of emergence delirium in children undergoing infraumbilical abdominal surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium using Paediatric Anaesthesia Emergence Delirium(PAED) scale
研究概览
简要总结
Emergence delirium is an acute state of confusion during recovery from anaesthesia. Incidence of emergence delirium in children ranges from 10 to 80% . Emergence delirium may have clinically significant consequences such as to patients or medical staffs, fallinf out of bed, bleeding at the surgical site, accidental removal of drain or intravenous catheters, unintented extubation , respiratory depression and increasing medical care cost. There is literature suggesting that some medication may prevent emergence delirium in children.Thus we plan to study the prevention of emergence delirium in children undergoing infraumbilical abdominal surgery by administering midazolam or propofol at the end of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA class 1&2.
排除标准
- •Children with developmental delay, psychological and neurological disorders, abnormal airway, respiratory disease and cardiovascular diseases.
结局指标
主要结局
Incidence of emergence delirium using Paediatric Anaesthesia Emergence Delirium(PAED) scale
时间窗: At baseline
次要结局
- Recovery time, Duration of sevoflurane administration, FLACCS Score in both groups, any adverse effects like nausea/vomiting,laryngospasm,desaturation,bronchospasm(FLACCS score measured at baseline)
研究者
Dr. Safiqur Rahman
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL,NEW DELHI