Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Number of Participants With Emergence Delirium (ED)
研究概览
简要总结
The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.
详细描述
Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating >=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating <0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane >= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-7 years
- •ASA I - II
- •Estimated surgery time < 2 hours
- •Sevoflurane induction and maintenance along with caudal block or Axillary Block
排除标准
- •Craniofacial anomalies
- •Difficult exposure of the vocal cordS
- •Invalid caudal block or axillary block
研究组 & 干预措施
low concentration (LC)
low concentration group
干预措施: Sevoflurane (Drug)
high concentration (HC)
high concentration group
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Number of Participants With Emergence Delirium (ED)
时间窗: within 30 minutes after awakening
The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score \>12. Higher score of PAED means a worse outcome.
次要结局
未报告次要终点