Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
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|ClinicalTrials.gov Identifier: NCT00484575|
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : May 20, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Reperfusion Injury Atrial Fibrillation||Drug: Sevoflurane Drug: propofol||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting|
|Study Start Date :||June 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||December 2008|
Active Comparator: propofol
propofol for sedation minimum 2 hours in CTICU after CABG
propofol given intravenously for sedation in control group
Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG
given by infusion via AnaConDa for sedation with target MAAS 2-3
Other Name: Sevorane
- Troponin levels [ Time Frame: 2 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484575
|Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit|
|Stockholm, Sweden, 171 76|
|Principal Investigator:||Peter V Sackey, MD, PhD||Karolinska Institutet, Institution of Physiology and Pharmacology, Section for Anesthesia and Intensive Care Medicine|
|Principal Investigator:||Jan-Olof Hellström, MD||Karolinska Institutet, Institution of Physiology and Phrmacology, Section for Anesthesia and Intensive Care|
|Principal Investigator:||Anders Öwall, MD, PhD||Karolinska University Solna, Department of Cardiothoracic Anesthesia and Intensive Care|