The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Emergence delirium
研究概览
简要总结
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children
详细描述
Children < 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started.
In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused.
Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 2 and 7 years
- •American Society of Anesthesiologist physical status 1 and 2
- •Children scheduled for opthalmic surgery
排除标准
- •Allergy history to any drugs
- •Risk of malignant hyperthermia
- •Neuromuscular disease
- •With arrhythmia
- •Any pulmonary, cardiac, hepatic and renal disease
研究组 & 干预措施
Magnesium group
Mg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends
干预措施: Magnesium (Drug)
Control group
Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends
干预措施: Saline (Drug)
结局指标
主要结局
Emergence delirium
时间窗: 30 minutes after anesthesia
Pediatric Anesthesia Emergence Delirium (PAED) scale
次要结局
- Pain score(At each two points: during emergence in operating room and 30 minutes after surgery ends)
- Nausea(At each two points: during emergence in operating room and 30 minutes after surgery ends)
- Duration of post-anesthetic care unit (PACU) stay(During 1 hour after surgery at PACU)
- vomiting(At each two points: during emergence in operating room and 30 minutes after surgery ends)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital