The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Intubation Condition
研究概览
简要总结
Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Care Provider, 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
- •ASA class I, II
排除标准
- •upper respiratory infection within 14 days
- •anticipated difficult intubation
研究组 & 干预措施
Ketamine 1
Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: Rocuronium (Drug)
Ketamine 1
Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: ketamine 1 (Drug)
Ketamine 1.5
Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: Rocuronium (Drug)
Ketamine 1.5
Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: ketamine 1.5 (Drug)
Ketamine 2
Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: Rocuronium (Drug)
Ketamine 2
Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
干预措施: ketamine 2 (Drug)
结局指标
主要结局
Intubation Condition
时间窗: during and after intubation, about 2 minute
5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing
次要结局
- heart rate(1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation)
- time for extubation(from the end of surgery to extubation, within 10 min)
- emergence agitation (4 points scale)(5 min after postanesthesia care unit (PACU) admission)
- PACU time(from PACU admission to discharge, about 30 min)
- severity of vomiting(1. 1 min after PACU admission 2. 30 min after PACU admission)
- Analgesic requirements (mg/kg)(during PACU stay, about 30 min)
- Desaturation(during PACU stay, about 30 min)
- blood pressure(1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation)
- frequency of vomiting(1. 1 min after PACU admission 2. 30 min after PACU admission)
研究者
Go Un Roh
principal investigator
Ajou University School of Medicine