Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Effect of inhaled milrinone on improvement of right ventricular function
研究概览
简要总结
The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.
详细描述
The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Cardiac surgery without CPB.
- •Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
- •Adult congenital heart disease planned for corrective surgery.
- •Contraindication to transesophageal echocardiography (TEE).
- •Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.
研究组 & 干预措施
(Group A) will receive milrinone
Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization
干预措施: Milrinone (Drug)
(Group B) will receive normal saline
Patients will receive 5 ml saline by nebulization over 5 min
干预措施: Normal saline (Drug)
结局指标
主要结局
Effect of inhaled milrinone on improvement of right ventricular function
时间窗: After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit
The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)
次要结局
未报告次要终点
研究者
samar mohammed
Lecturer of Anesthesia
Ain Shams University