A Pilot Study to Investigate Plasma Bupivacaine Concentrations in Children Receiving Total Intravenous Anaesthesia and Caudal Analgesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total and free plasma bupivacaine concentrations
研究概览
简要总结
The objective of this pilot study is to compare plasma [bupivacaine] between two groups of paediatric patients under general anaesthesia who will all receive regional caudal anaesthesia with bupivacaine: group 1 will receive TIVA and group 2 will receive a volatile anaesthetic.
详细描述
Hypothesis:
The investigators hypothesize that there will be a detectable difference in free plasma [bupivacaine] between these two treatment groups, with lower free plasma [bupivacaine] in the TIVA group.
Background:
Local anesthetics (LA) are frequently administered intra-operatively, in combination with general anaesthesia, for pain management in children. Although highly effective in this regard, LAs possess a narrow margin of safety. High plasma levels can cause toxicity in both the central nervous system (CNS) and the cardiovascular system (CVS) and may result from either the correct placement of an excessive dose or an inadvertent intravenous (IV) injection of a correct dose.
Specific Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TIVA
TIVA
干预措施: propofol (Drug)
Inhalational
Inhalational/volatile general anesthetic
干预措施: sevoflurane (Drug)
结局指标
主要结局
Total and free plasma bupivacaine concentrations
5 mL blood sample will be obtained at 15 and 30min. Total and free plasma bupivacaine concentrations
次要结局
未报告次要终点
研究者
Simon Whyte
Principle Investigator
University of British Columbia