Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- incidence of Emergence agitation
研究概览
简要总结
An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia.
The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile.
Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV.
This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Children scheduled for AT under general anesthesia (GA).
排除标准
- •Congenital cardiovascular anomalies
- •Behavioral changes
- •Delayed physical development
- •Children receiving sedatives or anticonvulsants therapy
研究组 & 干预措施
Group-A; ketamine/midazolam premedication
干预措施: ketamine/midazolam (Drug)
Group-B: Ketofol pre-extubation
干预措施: Ketofol (Drug)
结局指标
主要结局
incidence of Emergence agitation
时间窗: starting from time of PACU admission after recover from anesthesia till 6 hours postoperative
次要结局
未报告次要终点