A randomized comparative double blind study to evaluate the efficacy of levosimendan versus milrinone on reducing left atrial pressure in patients undergoing off pump coronary artery bypass grafting at SMS Medical College, Jaipur
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Ashna Fathima
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Mean Mitral early diastolic inflow velocity (E),
概览
简要总结
The study is to assess the comparative efficacy of levosimendan vs milrinone in reducing left atrial pressure in patients undergoing off pump coronary artery bypass grafting in SMS medical college Jaipur. The institutional ethics committee approval was obtained in october 2024.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade equal to or greater than 3 Patients with triple vessel coronary disease with ejection fraction greater than or equal to 40 percent.
排除标准
- •Patients with mitral regurgitation Patients who underwent conversion to on pump coronary artery bypass grafting Patients with critical left main coronary artery disease Patients undergoing redo surgery Patients with atrial fibrillation Patients with regional wall motion abnormalities Patients with mitral annular disorders Patients with preoperative use of Milrinone or Levosimendan or allergy to these drugs Patients who are a part of any other research study.
结局指标
主要结局
Mean Mitral early diastolic inflow velocity (E),
时间窗: T1 After sternotomy, | T2 During grafting of reverse saphenous venous graft in the proximal aorta, | T3 Grafting of left anterior descending artery, | T4 Grafting of obtuse marginal artery, | T5 Grafting of posterior descending artery, | T6 Before sternal closure
Mean Early diastolic mitral annular velocity (e’)
时间窗: T1 After sternotomy, | T2 During grafting of reverse saphenous venous graft in the proximal aorta, | T3 Grafting of left anterior descending artery, | T4 Grafting of obtuse marginal artery, | T5 Grafting of posterior descending artery, | T6 Before sternal closure
次要结局
- Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressure(baseline, postinduction 1 minute, after sternotomy, 30 minutes after induction, 6hrs after surgery, 12 hrs after surgery, 24 hrs after surgery)
- Central venous pressure, Cardiac index, Stroke volume variation, Systemic vascular resistance index
- complication, side effect(within 24 hrs of surgery)
研究者
Ashna Fathima
SMS Medical College, Jaipur