Recovery Profiles of Remifentanil-based vs. Sevoflurane-sufentanil Combined Regimen for Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Time to reach BIS > 80
研究概览
简要总结
Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).
Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.
The present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.
Analyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.
Materials and Methods:
During study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.
All patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.
As a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective coronary artery bypass surgery
排除标准
- •combined valve surgery
- •preoperative intraaortic balloon pumping
- •preoperative low cardiac output syndrome
- •chronic obstructive pulmonary disease
研究组 & 干预措施
remifentanil-based
remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60
干预措施: remifentanil-based (Drug)
sevoflurane-sufentanil balanced
balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen
干预措施: sevoflurane-sufentanil balanced (Drug)
结局指标
主要结局
Time to reach BIS > 80
时间窗: 1 minute
Time to reach BIS \> 80 after surgery
次要结局
- Extubation time(1 minute)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center
