Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- measure of postoperative pediatric anesthesia emergence delirium PAED score
研究概览
简要总结
Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The aim of the study is to delineate the effect of caudal magnesium sulfate in children undergoing lower abdominal surgery to prevent postoperative emergence agitation.
详细描述
Emergency agitation is considered one of the postoperative complication after sevoflurane anesthesia.In the enrollment of this study,children undergoing lower abdominal surgery will be enrolled in one of two groups.BM group, receive caudal magnesium sulfate 50 mg beside the conventional bupivacaine in the caudal space in ,B group, addition of 1 ml of normal saline0.9% to bupivacine .Monitoring of the postoperative emergence agitation by different emergence agitation scores with monitoring of sedation score.Detection of expected postoperative complications as nausea and vomiting.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •children undergoing lower abdominal surgery for hernia repair/orchiopexy in Ain Shams University ASA physical status I under sevoflurane anesthesia.
- •age from 1-6 years.
排除标准
- •children with developmental delay
- •neurological disorder.
- •psychological disorder
- •difficult airway
- •hyperactive airway disease
- •contraindication to caudal block(sacral abnormality,bleeding disorder).
研究组 & 干预措施
magnesium sulfate
magnesium sulfate 50mg caudal 1ml(5%) prepared after addition of 9ml of 0.9%normal saline to 1ml of 500mg(50%)of magnesium sulfate to be added to 1ml/kg of 0.25%of bupivacaine in caudal block in children undergoing lower abdominal surgery under sevoflurane anesthesia to prevent emergence agitation.
干预措施: Magnesium Sulfate (Drug)
o.9%normal saline
0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.
干预措施: 0.9%normal saline (Drug)
结局指标
主要结局
measure of postoperative pediatric anesthesia emergence delirium PAED score
时间窗: first 30 minutes postoperative
measurement of PAED score every 5 minutes in the first 30 minutes after lower abdominal surgery in children 1-6 year age after sevoflurane anesthesia.
次要结局
- measure of postoperative sedation score.(the first 30 minutes postoperatively)
研究者
Ashraf Elsayed Elagamy
ashraf elagamy
Ain Shams University