跳至主要内容
临床试验/NCT01572454
NCT01572454已完成不适用

The Comparison of Serum Potassium Concentration, Antiarrhythmic Effect, and Myocardial Protective Effect Between Dexmedetomidine and Remifentanil Infusion in Patients Undergoing Coronary Artery Bypass Surgery

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
serum potassium concentration

研究概览

简要总结

We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.

详细描述

Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.

Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those undergoing off-pump coronary artery bypass graft during March, 2012 ~ February, 2013 in Samsung Medical Center
  • Age between 20 and 70 yrs old

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

研究组 & 干预措施

Dexmedetomidine group

Experimental

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

干预措施: Dexmedetomidine infusion (Drug)

Remifentanil group

Active Comparator

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

干预措施: Remifentanil infusion (Drug)

结局指标

主要结局

serum potassium concentration

时间窗: 3 hour after start of anesthetic induction

serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)

次要结局

  • arterial blood gas analysis results(24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction)
  • incidence of hypokalemia(24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction)
  • hemodynamic parameters(24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction)
  • inotropics, vasopressor requirement(24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction)
  • Myocardial injury marker(2, 24, 48 hour after the end of surgery)
  • Left ventricular function(72 hour before, during (immediate after grafting), 72 hour after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyun Sung Cho

Professor

Samsung Medical Center

研究点 (1)

Loading locations...

相似试验