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Sponsored by: |
Karolinska Institutet |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00484575 |
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 | Intervention | Phase |
---|---|---|
Myocardial Reperfusion Injury Atrial Fibrillation |
Drug: Sevoflurane |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting |
Estimated Enrollment: | 120 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2007 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan-Olof Hellström, MD | +46706687420 | jan-olof.hellstrom@karolinska.se |
Contact: Peter V Sackey, MD, PhD | +46707710364 | peter.sackey@karolinska.se |
Sweden | |
Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit | Recruiting |
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 |
Study ID Numbers: | 2007-000293-23 |
Study First Received: | June 8, 2007 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00484575 |
Health Authority: | Sweden: Medical Products Agency |
Sevoflurane CABG cardioprotection AnaConDa |
Heart Diseases Postoperative Complications Myocardial Ischemia Vascular Diseases Ischemia Atrial Fibrillation |
Cardiomyopathies Myocardial Reperfusion Injury Sevoflurane Arrhythmias, Cardiac Reperfusion Injury |
Anesthetics, Inhalation Pathologic Processes Anesthetics, General Therapeutic Uses Physiological Effects of Drugs Hematologic Agents |
Central Nervous System Depressants Anesthetics Platelet Aggregation Inhibitors Cardiovascular Diseases Central Nervous System Agents Pharmacologic Actions |