Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
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Purpose
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 Drug: propofol |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting |
- Troponin levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]
- renal function [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- ambient sevoflurane levels [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
- cognitive function/memory panorama post ICU [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- attenuation of inflammatory response [ Time Frame: 2 days ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: propofol
propofol for sedation minimum 2 hours in CTICU after CABG
|
Drug: propofol
propofol given intravenously for sedation in control group
Other Name: Propofol
|
|
Experimental: sevoflurane
Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG
|
Drug: Sevoflurane
given by infusion via AnaConDa for sedation with target MAAS 2-3
Other Name: Sevorane
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Planned coronary artery bypass grafting
Exclusion Criteria:
- Combined heart valve surgery
- Malignant Hyperthermia
- Postoperative need for mechanical circulation support
Contacts and Locations| Sweden | |
| 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 |
More Information
No publications provided
| Responsible Party: | Peter Sackey, MD, PhD, Dept of Physiology and Pharmacology, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00484575 History of Changes |
| Other Study ID Numbers: | 2007-000293-23 |
| Study First Received: | June 8, 2007 |
| Last Updated: | May 19, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Karolinska Institutet:
|
Sevoflurane CABG cardioprotection AnaConDa |
Additional relevant MeSH terms:
|
Atrial Fibrillation Myocardial Reperfusion Injury Reperfusion Injury Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cardiomyopathies Myocardial Ischemia Vascular Diseases Postoperative Complications Propofol Sevoflurane |
Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on May 16, 2013