Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、135-710
- Samsung Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
其他名称:
|
|
实验性的: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
|
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
其他名称:
|
|
实验性的:Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
|
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
其他名称:
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
其他名称:
|
|
无干预:Control group
The group without infusion of lidocaine or dexmedetomidine
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Myocardial injury marker
大体时间:postoperative ICU day 1
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 1
|
|
Myocardial injury marker
大体时间:postoperative ICU day 2
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 2
|
|
Myocardial injury marker
大体时间:postoperative ICU day 3
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The blood sodium, potassium, calcium level
大体时间: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
大体时间: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: Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing |
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
|
Postoperative ICU stay, Hospital stay, Extubation time
大体时间:1 day after hospital discharge
|
Postoperative ICU stay, Hospital stay
|
1 day after hospital discharge
|
|
Inotropics use during and after the surgery
大体时间: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 and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil
|
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 hypokalemia
大体时间: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 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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2012-07-098-001
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.