NCT01212523已完成4 期
Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.
University Hospitals Bristol and Weston NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年11月1日最近更新:
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相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
研究概览
简要总结
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Months 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study.
排除标准
- •Children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.
结局指标
主要结局
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
时间窗: 2 hours
次要结局
- The secondary endpoints are the percentage change in mean pulomanry artery pressure (PAP), systemic vascular resistance (SVR) and mean arterial pressure (MAP).(2 hours)
研究者
Michelle White
Consultant in Paediatric Anaesthesia and Critical Care
University Hospitals Bristol and Weston NHS Foundation Trust
研究点 (2)
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