Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 试验地点
- 1
- 主要终点
- incidence of emergence agitation at different time interval after emergence
研究概览
简要总结
Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. In infants, there is a high incidence of emergence agitation (EA) after desoflurane anesthesia. The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia
详细描述
subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years group, and 3-12 years group. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery
- •Patients who are American Society of Anesthesiologists classification I and II
- •Patients who are 4 months through 15 years of age
排除标准
- •children with history of respiratory tract infection 1 week preoperatively.
- •patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities.
- •patients with any congenital malformation or acquired disease that could increase the risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital heart disease, hydronephrosis, nutrition dysplasia).
- •patients with long-term use of sedative or analgesic drugs.
研究组 & 干预措施
0.4ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
干预措施: 0.4ug/kg dexmedetomidine (Drug)
0.6ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
干预措施: 0.6ug/kg dexmedetomidine (Drug)
0.2ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
干预措施: 0.2ug/kg dexmedetomidine (Drug)
0.8ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
干预措施: 0.8ug/kg dexmedetomidine (Drug)
1.0ug/kg dexmedetomidine
Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
干预措施: 1.0ug/kg dexmedetomidine (Drug)
结局指标
主要结局
incidence of emergence agitation at different time interval after emergence
时间窗: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
emergence agitation was evaluated by five-point scale
次要结局
- sedation scales at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)
- incidence of emergence delirium at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)
- pain scale at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)
研究者
Ying Jun She, MD
Dr.
Guangzhou Women and Children's Medical Center