跳至主要内容
临床试验/NCT02499445
NCT02499445已完成不适用

Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年11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
120
试验地点
1
主要终点
troponin I

研究概览

简要总结

In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).

详细描述

To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.

Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).

Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient undergoing OPCAB surgery
  • patient signed written informed consent

排除标准

  • patient with Intra-aortic balloon pump
  • patient with renal replacement therapy
  • patient wants to withdraw the participation to the study

研究组 & 干预措施

Remifentanil and propofol

Active Comparator

remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)

干预措施: Remifentanil (Drug)

Remifentanil and propofol

Active Comparator

remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)

干预措施: propofol (Drug)

remifentanil and sevoflurane 1

Active Comparator

remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)

干预措施: Remifentanil (Drug)

remifentanil and sevoflurane 1

Active Comparator

remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)

干预措施: sevoflurane 1 (Drug)

sevoflurane 2 and sufentanil

Active Comparator

sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)

干预措施: sevoflurane 2 (Drug)

sevoflurane 2 and sufentanil

Active Comparator

sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)

干预措施: sufentanil (Drug)

结局指标

主要结局

troponin I

时间窗: one day after surgery

troponin I for myocardial injury

次要结局

  • creatinin kinase-MB(one day after surgery)

研究者

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

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

研究点 (1)

Loading locations...

相似试验