The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- objective pain score
研究概览
简要总结
Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patient undergoing the strabismus surgery in severance hospital
排除标准
- •delayed development
- •mental retardation
- •cerebral palsy
- •preoperative EKG abnormality e.g. cardiovascular conduction disorder
研究组 & 干预措施
dexmedetomidine
干预措施: Dexmedetomidine (Drug)
placebo
干预措施: placebo group (Drug)
结局指标
主要结局
objective pain score
时间窗: immediate postoperative period up to 1hour after surgery
1. Objective pain score(OPS) Blood pressure 0\~2 points crying 0\~2points movement 0\~2points agitation 0\~2points posture 0\~2points complain of pain(where appropiraate by age) 0\~2points total 0\~10 points
pediatric anesthesia emergence delirium (PAED) scale
时间窗: immediate postoperative period up to 1hour after surgery
2. pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0\~4 The child's actions are purposeful. 0\~4 The child is aware of his'her surroundings. 0\~4 The child is restless. 0\~4 The child is insonsolable. 0\~4 total 0\~20 points
5-point agitation scale
时间窗: immediate postoperative period up to 1hour after surgery
3. Scoring system for emergence agitation (behavior score) 1. Sleeping 2. Awake and calm 3. Irritable and crying 4. Inconsolable crying 5. Severe restlessness and disorientation
次要结局
未报告次要终点