Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Duration of Apnea
研究概览
简要总结
The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.
详细描述
Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 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 3-12 years
- •Unpremedicated
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 2.0 mg/kg + Remifentanil 1.5 ug/kg
干预措施: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg (Drug)
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
干预措施: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg (Drug)
结局指标
主要结局
Duration of Apnea
时间窗: This outcome was measured for the duration of the procedure (lumbar puncture).
Duration of no respiratory effort
Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
时间窗: This outcome was measured for the duration of the recovery phase.
次要结局
- Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.(This outcome was measured for the duration of the procedure (lumbar puncture).)
研究者
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children