ACTRN12606000441516已完成4 期
A multi-site randomised controlled trial comparing bupivacaine (regional) anaesthesia versus sevoflurane (general) anaesthesia for effects on neurodevelopmental outcome and apnoea in infants scheduled for unilateral or bilateral inguinal hernia repair
Professor Andrew Davidson0 个研究点目标入组 720 人开始时间: 2006年10月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 26 Weeks 至 60 Weeks（—）
- 性别
- All
入选标准
- •* Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision) * Any infant whose gestational age is 26 weeks or more (GA = 182 days)* Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)
排除标准
- •* Any child older than 60 weeks post menstrual age * Any child born at less than 26 weeks gestation * Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)* Pre-operative ventilation immediately prior to surgery* Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy* Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development* Children where follow-up would be difficult for geographic or social reasons* Families where English (or French for Paris and Montreal sites) is not the language spoken at home* Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular haemorrhage (IVH) (+/- post haemorrhage ventricular dilatation)* Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero.
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