A Prospective Randomized Double blinded Comparative study to assess the effects of Dexmedetomidine on postoperative renal function in patients undergoing valve surgery under cardiopulmonary bypass in SMS Medical College Jaipur
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Comparison of Mean changes in renal function pre-op and post op 48 hrs after surgery by measuring Serum Creatinine and Blood Urea.
研究概览
简要总结
Valvular heart disease is the most common structural heart disease and refers to the abnormal anatomic structure and function of the heart valve or peri valvular tissue caused by rheumatism, degeneration, infection, and congenital developmental malformations. AKI is a common complication with an estimated incidence about 7% to 45% in adult cardiac surgery.Dexmedetomidine, a highly selective alpha adrenoreceptor agonist, induces sedation, analgesia, hemodynamic stabilization, anti-inflammation, as well as diuresis. It’s perioperative administration could reduce AKI incidence in patients undergoing cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give consent.
- •Patients of 18 to 80 years of age scheduled for cardiac valve replacement/valvuloplasty with either a single valve or multiple valves under CPB.
- •ASA grade 2 and 3.
排除标准
- •1.Non-cooperative patient.
- •2.Patients with BMI more than or equals to 30kg/m
- •Patients with pre-op pulmonary infection, liver insufficiency, kidney insufficiency.
- •Patients with history of use of nephrotoxic drugs and contrast agents used within 48 hours.
结局指标
主要结局
Comparison of Mean changes in renal function pre-op and post op 48 hrs after surgery by measuring Serum Creatinine and Blood Urea.
时间窗: Comparison of Mean changes in renal function pre-op and post op 48 hrs after surgery by measuring Serum Creatinine and Blood Urea.
次要结局
- 1.Comparison of Mean changes in Intraoperative Haemodynamics (MAP and HR).(2.Comparison of Mean Changes in serum indices C reactive protein levels in both the groups.)
研究者
Dr Indu Verma
Sawai Man Singh Medical College and Hospitals