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临床试验/NCT00484575
NCT00484575已完成1 期

Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Troponin levels

研究概览

简要总结

Inhaled sevoflurane during coronary artery bypass grafting (CABG) reduces postoperative Troponin levels and may be associated with improved outcome. A dose-response effect has been demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used during the entire operation, as compared to Sevoflurane during parts of the operation.

Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. Postoperative sedation after CABG is currently achieved with intravenous propofol.

A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.

The primary aim (and primary hypothesis)of the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional propofol sedation.

Other end-points of the trial are potential renal (protective) effects measured with cystatin C levels, need for dialysis but also measurements of inorganic fluorides in serum, as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit. Furthermore, potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires.

Besides routine blood sampling, plasma will be saved for later analysis of inflammatory mediators (biobank).

详细描述

Sevoflurane, an inhaled anesthetic is currently recommended for anesthesia during coronary artery bypass grafting (CABG).

Inhaled sevoflurane during CABG reduces postoperative Troponin levels and may be associated with improved outcome. A dose-response effect of Sevoflurane cardioprotection has been demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used during the entire operation, as compared to Sevoflurane during parts of the operation or not at all.

Postoperative sedation after CABG is currently achieved with intravenous propofol.

Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group. The Anesthetic Conserving Device (AnaConDa®) is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device. Studies of isoflurane sedation with the AnaConDa® have shown good sedation effects and short wake-up times.

The primary aim (and primary hypothesis)of the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional propofol sedation.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Planned coronary artery bypass grafting

排除标准

  • Combined heart valve surgery
  • Malignant Hyperthermia
  • Postoperative need for mechanical circulation support

研究组 & 干预措施

propofol

Active Comparator

propofol for sedation minimum 2 hours in CTICU after CABG

干预措施: propofol (Drug)

sevoflurane

Experimental

Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Troponin levels

时间窗: 2 days

次要结局

  • renal function(1 week)
  • ambient sevoflurane levels(2 days)
  • cognitive function/memory panorama post ICU(1 week)
  • attenuation of inflammatory response(2 days)

研究者

申办方类型
Other

研究点 (1)

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