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临床试验/NCT02400879
NCT02400879已完成不适用

Comparisons of Postoperative BIS Profile and Extubation Time After Valvular Heart Surgery: Remifentanil-based Propofol-supplemented Versus Sevoflurane-sufentanil Balanced Anesthesia Regimen

Konkuk University Medical Center0 个研究点目标入组 38 人开始时间: 2015年10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
38
主要终点
time to achieving BIS>80

研究概览

简要总结

Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac anesthesia, its recovery profile in cognitive function has not been investigated. Authors determined postoperative Bispectral index (BIS) score as well as extubation time after remifentanil-based propofol-supplemented anesthesia and compared them with those after conventional balanced sevoflurane-sufentanil anesthesia.

Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS < 60 (< 1.5 MAC) in Group C, respectively.

Authors will analyze postoperative recovery of cognitive function by using BIS after the use of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.

详细描述

Backgrounds Since opioid-based anesthesia does not produce dose-dependent myocardial depression, it has been applied for patients undergoing cardiac surgery with myocardial dysfunction.

However, prolonged use of conventional opioids in a large dosage delays patient's postoperative recovery due to their longer half-life and accumulation of their metabolites.

Fast-track cardiac anesthesia which reducing the duration of postoperative mechanical ventilation and length of stay (LOS) in the intensive care unit (ICU) is beneficial not only in reducing ventilator-related complications and medical expense but in improving patient's outcome.

For this purpose, in addition to supplementation of neuraxial blockade, use of short-acing opioid, such as remifentanil, has been advocated for cardiac anesthesia. Remifentanil is an ultra-short acting opioid and provides not only stable hemodynamics, as other opioid does, and but fast recovery, even after prolonged use in a large dosage. In further, recent investigations showed that remifentanil provides preconditioning effect in myocardial ischemia injury during cardiac surgery, as like in the use of volatile anesthetics including sevoflurane.

Remifentanil vs volatile anesthetics In spite of the importance of recovery of cognitive function on whole postoperative clinical features, most investigations have evaluated only the postoperative respiratory profile in determining the speed of postoperative recovery specific to the choice of anesthesia regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients undergoing cardiac valve repair or replacement surgery under moderate hypothermic cardiopulmonary bypass (CPB).
  • All patients should provide written informed consents

排除标准

  • Preoperative exclusion criteria
  • urgent or emergent surgery,
  • left ventricle (LV) ejection fraction < 50%,
  • application of intraaortic balloon pump (IABP),
  • myocardial infarction,
  • neurologic deficit,
  • hepatic or renal impairment,
  • inotropic medication,
  • neurologic deficit.
  • Intraoperative exclusion criteria
  • CPB application > 250 min,
  • transfused of packed red blood cell (pRBC) > 5 units,
  • post-CPB use of double inotropic support > 30 min ,
  • post-CPB pacing,
  • postoperative hemodialysis,
  • excessive bleeding > 750 ml during postoperative 6 hour,
  • reoperation due to excessive bleeding.

研究组 & 干预措施

Remifentanil

Active Comparator

For anesthesia maintenance, TCI-remifentanil (fixed Cp of 20 ng/ml) and TCI-propofol (variable Ce < 2.0 µg/ml) for maintaining BIS 40-60

干预措施: Remifentanil (Drug)

sevoflurane and sufentanil

Placebo Comparator

TCI-sufentnail (Cp of 0.4-0.8 ng/ml) and sevoflurane (< 1.5 MAC) for maintaining 80-120 % of preoperative value and BIS < 60

干预措施: sevoflurane and sufentanil (Drug)

结局指标

主要结局

time to achieving BIS>80

时间窗: 5 min

The duration from the end of surgery to the time of achieving BIS score \> 80 (BIS\>80 persisting \> 3 min)

次要结局

  • time to achieve extubation(5 min)
  • time to achieve SIMV ventilation mode(5 min)

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

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