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临床试验/NCT01212523
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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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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

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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