Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Emergence delirium
研究概览
简要总结
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)
详细描述
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) will receive dexmedetomidine 1 µg/kg IV over 10 minutes and midazolam 0.1 mg/kg IV as a bolus concomitant with induction, followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h and midazolam at 0.1 mg/kg/h for maintenance.
Group KM (Ketamine + Midazolam) will receive ketamine 1 mg/kg IV and midazolam 0.1 mg/kg IV as a bolus for induction, followed by a continuous infusion of ketamine at 1 mg/kg/h and midazolam at 0.1 mg/kg/h.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective cardiac catheterization under general anesthesia.
排除标准
- •neurological disorder, psychiatric disease, or current psychoactive medication.
- •significant systemic comorbidities.
研究组 & 干预措施
Dexmedetomidine-Midazolam
Children will receive Dexmedetomidine + Midazolam
干预措施: Dexmedetomidine and Midazolam (Drug)
ketamine-Midazolam
Children will receive ketamine + Midazolam
干预措施: Ketamine and Midazolam (Drug)
结局指标
主要结局
Emergence delirium
时间窗: 30 minutes post-anesthesia
Incidence of emergence delirium assessed using the PAED scale
次要结局
未报告次要终点
研究者
Ahmed Mohamed Mohamed Elhaddad
Assisstent Professor
Kasr El Aini Hospital