Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time of emergence
研究概览
简要总结
Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%.
The purpose of this study is to verify that the prophylactic use of midazolam, which is a GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces the incidence of emergence agitation after sevoflurane anesthesia in children. Simultaneously, this study aims to find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
详细描述
Sevoflurane is associated with a high incidence of emergence agitation in children. The etiology of emergence agitation is unclear. Some studies proposed that emergence agitation was related to a variable rate of neurologic recovery rate in different brain areas and immaturity of neurons. Inhalation anesthetics have been known to exert transient paradoxical excitatory effects in both animals and human patients, especially in children. The gamma(γ)-aminobutyric acid (GABA)A receptor is the target depressant effect site of most anesthetic drugs including sevoflurane. Midazolam acts on the benzodiazepine binding site of GABAA receptors and results in inhibitory effects on the central nervous system. The effect of midazolam premedication, as well as midazolam administration at the end of surgery, on suppressing emergence agitation has been studied. However, the effect of midazolam on emergence agitation is still controversial. This study aims to figure out the effect of midazolam at the end of surgery on emergence agitation during the recovery period, and find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I and II patients
- •Aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia
- •Willing to be assigned to any of the study intervention groups
排除标准
- •Refusal by parents
- •Neurological disease
- •Developmental delay
- •History of any previous surgery
- •Airway disease
- •American Society of Anesthesiologists physical status score of III or IV
研究组 & 干预措施
Midazolam 0.03mg/kg
This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
干预措施: Midazolam 0.03mg/kg (Drug)
Midazolam 0.05mg/kg
This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
干预措施: Midazolam 0.05mg/kg (Drug)
Placebo
This group will be injected intravenous normal saline five minutes before the end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Time of emergence
时间窗: within the first 1hour after end of surgery
The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.
次要结局
- Incidence of emergency agitation(From just after extubation until the discharge of PACU, assessed up to 1 hour)
研究者
Eun Jung Cho
Anesthesiology and Pain Medicine Department
Korea University Anam Hospital