The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- the incidence of emergence agitation (EA)
研究概览
简要总结
This study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery
详细描述
Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after general anesthesia. There are several suggested causes of EA and pain has been considered one of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years
排除标准
- •ASA class ≥ III
- •imbalance of electrolyte
- •myocardial damage or conduction abnormality on ECG
- •myasthenia gravis or any other neuromuscular disease
- •impaired renal function
- •denial to participate in study or not be able to give informed consent
研究组 & 干预措施
Normal saline(NS) group
loading 50mL of normal saline during 10minutes before starting of surgery, after starting of surgery, continuous infusion of normal saline as placebo by 0.15mg/kg/h until the end of surgery
干预措施: Normal saline (Drug)
Magnesium group
loading dose of 50mg/kg magnesium sulfate during 10minutes before starting of surgery, during the surgery, continuous infusion of magnesium sulfate by 15mg/kg/h
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
the incidence of emergence agitation (EA)
时间窗: 15 minute interval at the post-anesthetic care unit (PACU)
Using PAED (pediatric anesthesia emergence delirium) score, consider the score 10 or more as occuring of EA. Comparing the score between the placebo group and the intervention group for the difference of the incidence of EA.
次要结局
- the severity of EA(15 minute interval at the post-anesthetic care unit (PACU))
研究者
LEE YEA JI
clinical professor
Seoul National University Bundang Hospital