A prospective randomized double blind study to assess the cardioprotective role of melatonin in patients undergoing coronary artery bypass graft surgery
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of effect of preoperative oral melatonin on postoperative levels of cardiac biomarkers Trop-I, CK-MB ,highly sensitive CRP
研究概览
简要总结
Coronary artery disease is one of the most common human disease .Angioplasties and coronary artery bypass grafts are two methods for treating coronary artery diseases. Injuries from ischemia - reperfusion following heart surgery are one of the most serious issues causing serious complications. Recently melatonin has emerged as potent , direct,free radical scavenger and indirect antioxidant.Therefore present study aims at assessing the effect of preoperative oral melatonin administration on preoperative anxiety ,Postoperative changes in levels of cardiac biomarkers CKMB,TROP-I, hs-CRP ,Postoperative pain and delirium.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing elective coronary artery bypass graft surgery BMI 18-40 kg/m2 ASA grade 1-3.
排除标准
- •Patient refusal Emergency coronary artery bypass graft surgery Re-exploration coronary artery bypass graft surgery Concomitant valve surgery Associated severe lung disease or liver disease Ejection fraction less than 30% Patients with pace maker Patients on antidepressants and mood stablizers.
结局指标
主要结局
Assessment of effect of preoperative oral melatonin on postoperative levels of cardiac biomarkers Trop-I, CK-MB ,highly sensitive CRP
时间窗: 1 year
次要结局
- To assess the effect of postoperative melatonin on :(1.preoperative anxiety)
研究者
Anushka gautam
Jawaharlal Nehru medical college Aligarh Muslim university