NCT02244515Unknown4 期
Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
Jin Ni0 个研究点目标入组 80 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Heart rate
研究概览
简要总结
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.
排除标准
- •Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications
研究组 & 干预措施
Group D
Experimental
Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Heart rate
时间窗: during surgical procedures
pediatric anesthesia emergence delirium (PAED) scale
时间窗: during stay in postanesthesia care unit
systolic blood pressure
时间窗: during surgical procedures
diastolic blood pressure
时间窗: during surgical procedures
次要结局
未报告次要终点
研究者
Jin Ni
Vice-administrator of Department of Anesthesiology
Guangzhou Women and Children's Medical Center
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