The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Agitation score
研究概览
简要总结
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.
详细描述
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical status classification of American Society of Anesthesiologist 1-2,
- •Healthy, normal
- •2-6 years old
- •Elective operation
排除标准
- •Lack of consent
- •Known adverse effects to dexmedetomidine, mental retardation
- •Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
- •No cardiac disease
研究组 & 干预措施
Dexmedetomidine0.25
dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine0.5
dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine1.0
dexmedetomidine 1 microg.kg(-1) ivs. for 10min.
干预措施: Dexmedetomidine (Drug)
NormalSaline
Normal saline 10ml ivs. for 10min.
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Agitation score
时间窗: 30 mins after operation
次要结局
- Oculomotor reflex(Intraoperative)
研究者
Ah-Young Oh
Assistant Professor
Seoul National University Hospital