Effects of remote ischemic preconditioning in patients undergoing off pump coronary artery bypass grafting procedure-A Randomised controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Remote ischemic preconditioning will be associated with reduced perioperative concentration of cardiac troponin I in patients undergoing off pump coronary artery bypass grafting procedure
研究概览
简要总结
After getting informed written consent , patients will be randomly allocated into two groups by computer generated random numbers.
Group A - Patients receiving remote ischemic preconditioning
Group B - Patients free of remote ischemic preconditioning
The patients in both the group will be premedicated with tablet Alprazolom 0.25mg on the night before surgery
On the day of surgery patients in both the groups will be shifted on to the table and baseline monitors ie., non invasive bloop pressure , pulse oximetry and electrocardiography will be attached and baseline values will be recorded.
Peripheral line will be secured with 16G venflon. Arterial line will be secured in left radial artery.Central venous pressure line will be secured in right internal jugular vein.Blood pressure cuff will be tied in right upper limb and left lower limb.Arterial blood pressure , Central venous pressure , lead 2 and 5 of ECG and nasopharyngeal temperature will be recorded will be recorded continuously.
Before induction of anaesthesia, patients will be premedicated with Midazolam 0.05mg/kg.After adequate preoxygenation with 100% oxygen for 6 minutes , patients will be induced with Fentanyl 3mcg/kg , Etomidate 0.2 mg/kg and muscle relaxant vecuronium 0.1mg/kg .Trachea will be intubated with cuffed endotracheal tube and put on mechanical ventilation in volume control mode maintained using oxygen and nitrous oxide.Volatile agents sevoflurane will be used till 40 - 60 % of bispectral index attained.
Remote ischemic preconditioning and control protocol will be initiated.One standard blood pressure cuff will be placed on right upper limb and other cuff on left lower limb.Before sternotomy incision the cuff will be inflated simultaneously to 200mmhg for 5 minutes and the deflated to 0 mmhg for 5 minutes.The cycle will be repeated four times so that the total duration of remote ischemic preconditioning will be 20 minutes.
For control group(Group B)the cuff will placed on right upper arm and left lower limb.
After all the grafts have been placed , the surgeons ensures that there is no bleeding from the graft sites and that the bypass grafts are functioning properly.The heart then carefully will be repositioned and the pericardium and sternum will be closed with sutures.
The patients will be shifted to cardiac ICU and closely monitored
The primary end point cardiac troponin I levels will be assessed At 24hr,48hr,72hr after cardiac bypass grafting.Urea,serum creatinine will be assessed every 24 hrs
The secondary end point including the component of primary end point will be assessed at 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1.Patient undergoing primary , elective OFF pump coronary bypass grafting procedure for double/triple coronary artery disease.
- •2.ASA 3 and 4.
排除标准
- •1.Patient in cardiogenic shock 2.Cardiac arrest in current hospital admission
- •Pregnancy
- •Disease related to preoperative renal insufficiency , peripheral vascular disease , inotropic support before induction of anesthesia.
结局指标
主要结局
Remote ischemic preconditioning will be associated with reduced perioperative concentration of cardiac troponin I in patients undergoing off pump coronary artery bypass grafting procedure
时间窗: Cardiac troponin I will be assessed at 24 hr,48hr,72hr postoperatively
次要结局
- 1.Incidence of intraoperative and postoperative arrhythmia in first 72 hours.(2.Acute Kidney injury)
研究者
Iswarya S
SRM Medical College Hospital and Research Institute