The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
研究概览
简要总结
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
详细描述
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of a hemato-oncological disorder
- •Scheduled to undergo a lumbar puncture
- •Aged 4-11 years
- •Male or female
- •Unpremedicated
- •Willing and able to provide informed consent (or informed consent by parents)
排除标准
- •Children who are known or suspected to be difficult to ventilate by face mask
- •Children who are deemed medically unfit to receive either of the two study medications
- •Children who are obese (weight for height > 95th percentile,
- •Children who do not have an indwelling intravenous line
研究组 & 干预措施
Propofol 4 mg/kg group
First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
干预措施: Remifentanil (Drug)
Propofol 2 mg/kg group
First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
干预措施: Remifentanil (Drug)
结局指标
主要结局
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
时间窗: Movement measured at the time of lumbar puncture needle insertion.
Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion
次要结局
- Incidence of Adverse Events.(Followed for the length of the procedure.)
研究者
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children