Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Reduction pulmonary artery pressure
研究概览
简要总结
The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.
详细描述
Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing an informed consent form,
- •Aged 18 to 80 years
- •Pulmonary hypertension due to left heart disease,
- •Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists,
- •Subjected to cardiac circulation with extracorporeal circulation
排除标准
- 未提供
研究组 & 干预措施
Clonidine
Administration of 2 μg/kg of intravenous clonidine.
干预措施: Clonidine (Drug)
Placebo
Injection of placebo solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction pulmonary artery pressure
时间窗: During intraoperative (hours)
Assessed four times: before (T0) administration of 2 μg·kg-1 of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after ECC (T2), and 10 minutes after the injection of protamine (T3).
次要结局
- Doses of Dobutamine(During intraoperative (hours))
- Doses of Sodium nitroprusside(During intraoperative (hours))
研究者
Luiz Fernando dos Reis Falcao
Clinical Professor
Federal University of São Paulo