Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Incidence of sevoflurane induced post anesthesia agitation
研究概览
简要总结
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.
详细描述
This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.
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
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no cardiovascular, respiratory or neurologic congenital anomalies
- •no allergic reactions, or any contraindication to drugs used in this trial ever documented
排除标准
- •congenital anomalies recognized/diagnosed during trial procedures
- •hemmorhage > 15% EBV
- •shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)
研究组 & 干预措施
diphenhydramine
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Diphenhydramine (Drug)
diphenhydramine
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Ketamine (Drug)
diphenhydramine
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Sevoflurane (Drug)
diphenhydramine
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Bupivacaine (Drug)
control
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: normal saline (Drug)
control
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Ketamine (Drug)
control
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Sevoflurane (Drug)
control
Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Incidence of sevoflurane induced post anesthesia agitation
时间窗: 10 minutes post extubation
次要结局
- Amount of rescue Ketamine used(1 minute post extubation, at emergence, 15 minute post extubation)
- Significant adverse events(1 minute post extubation, at emergence, 15 minute post extubation)
- Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)(15 minute post extubation)
- Incidence of sevoflurane induced post anesthesia agitation(15 minute post extubation)
- Length of stay in recovery room(up to 15 minutes post extubation)
研究者
Ika Cahyo Purnomo
Doctor
Universitas Diponegoro