The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Myocardial injury marker
研究概览
简要总结
The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.
详细描述
Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.
Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.
Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
排除标准
- •Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
- •Patients with recent exogenous steroid administration or previous diuretics therapy
- •Patients with recent myocardial infarction
- •Those undergoing unplanned cardiopulmonary bypass during the surgery
研究组 & 干预措施
Lidocaine group
a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
干预措施: Lidocaine infusion (Drug)
Dexmedetomidine group
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
干预措施: Dexmedetomidine infusion (Drug)
Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
干预措施: Lidocaine infusion (Drug)
Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
干预措施: Dexmedetomidine infusion (Drug)
结局指标
主要结局
Myocardial injury marker
时间窗: postoperative ICU day 3
Myocardial injury marker - CK-MB, and Troponin(i) blood level
次要结局
- Postoperative ICU stay, Hospital stay, Extubation time(1 day after hospital discharge)
- The incidence of hypokalemia(1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3)
- The blood sodium, potassium, calcium level(1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3)
- The incidence of arrhythmia during and after the surgery(1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3)
- Inotropics use during and after the surgery(1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3)
研究者
Hyun Sung Cho
Professor
Samsung Medical Center