Clinical Trial: Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

Brief Summary:

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 w

Detailed Summary:

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.

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 asp
Sponsor: Karolinska Institutet

Current Primary Outcome: Troponin levels [ Time Frame: 2 days ]

Original Primary Outcome: Troponin and BNP levels [ Time Frame: 2 days ]

Current Secondary Outcome:

  • renal function [ Time Frame: 1 week ]
  • ambient sevoflurane levels [ Time Frame: 2 days ]
  • cognitive function/memory panorama post ICU [ Time Frame: 1 week ]
  • attenuation of inflammatory response [ Time Frame: 2 days ]


Original Secondary Outcome:

  • renal function [ Time Frame: 1 week ]
  • ambient sevoflurane levels [ Time Frame: 2 days ]
  • cognitive function and memory panorama post ICU [ Time Frame: 1 week ]
  • attenuation of inflammatory response [ Time Frame: 2 days ]


Information By: Karolinska Institutet

Dates:
Date Received: June 8, 2007
Date Started: June 2007
Date Completion:
Last Updated: May 19, 2010
Last Verified: June 2007