A Comparison of Two Anaesthetic Methods of Protecting Heart Tissue During Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00244283|
Recruitment Status : Unknown
Verified October 2005 by Golden Jubilee National Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 26, 2005
Last Update Posted : October 26, 2005
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Surgery||Drug: Sevoflurane Procedure: High thoracic epidural analgesia||Phase 4|
Coronary artery bypass grafting (CABG) is a common procedure performed to improve blood flow to the heart in patients with severe ischaemic heart disease. Commonly, the heart has to be stopped to allow this procedure to be performed and this is often achieved with cooling the heart and perfusing it with a solution that stops the activity of the heart muscle. These techniques stop the heart from beating which allows the surgery to be performed and also reduce the oxygen requirements of the heart. This in turn reduces the damage the heart suffers from the reduced blood flow to it which occurs while the arteries are being operated on. Unfortunately, however, these techniques do not completely eliminate the risk of heart muscle damage and so new methods of further reducing damage to the heart are continually being investigated. Two methods relating to the anaesthetic techniques used have recently been identified as potentially of benefit in this regard – the use of volatile anaesthetic agents and the use of high thoracic epidural analgesia.
Volatile anaesthetic agents have been extensively investigated in the past few years with regard to their apparent ability to mimic ischaemic preconditioning. Ischaemic preconditioning refers to the phenomenon that if heart tissue is exposed to frequent, short episodes of reduced blood or oxygen supply, followed by a longer spell, the heart is likely to suffer a smaller area of damage than if it had never been exposed to the brief ischaemic spells. This can be related clinically to the observation that patients with angina, who subsequently suffer a heart attack, have a better prognosis than those patients who suffer a heart attack without ever experiencing angina prior to the event. There have been numerous studies demonstrating that the volatile anaesthetic agents (isoflurane, sevoflurane, desflurane) appear to mimic this phenomenon, both in animal and human models. Numerous studies have demonstrated favourable postoperative blood concentrations of cardiac troponin I (a sensitive marker of heart damage), CK-MB (another marker of heart damage), atrial and brain natriueretic peptides (markers of heart function) compared to those who did not receive preconditioning. It has therefore been suggested that this may improve outcome following cardiac surgery.
High thoracic epidural analgesia (HTEA) has also been shown to be beneficial following cardiac surgery. This involves placing a small catheter near the nerves as they leave the spinal cord. Local anaesthetic ccan be administered down this catheter to numb the areas of the body supplied by these nerves. This provides very good pain relief and is widely used in our hospital for this operation. It has been shown to be associated with a shorter time of required artificial ventilation compared to standard pain relief with drugs such as morphine. It has also been suggested that it may influence outcome with improved heart function following the operation compared to those without HTEA. It appears to do this by improving the blood flow to the heart. It has also been associated with a lower postoperative concentration of cardiac troponin , CK-MB, atrial and brain natriuretic peptides. There has not been any direct comparison of the two techniques, however, to assess if one is superior to the other, or if the benefits of the two techniques are additive.
This study aims to assess if one technique confers more benefit than the other and if the benefits are additive. This is important as many centres do not use thoracic epidural analgesia for cardiac surgery and not all clinicians currently use volatile anaesthetics for cardiac surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Myocardial Protection Using Preconditioning With Sevoflurane Against High Thoracic Epidural Analgesia for CABG Surgery|
|Study Start Date :||January 2006|
|Estimated Study Completion Date :||January 2008|
- Plasma concentration of NT-proBNP as a biochemical marker of ventricular dysfunction
- Changes in plasma measurements of cardiac troponin I and CK-MB from baseline over the first two poatoperative days.
- Cardiac morbidity/ mortality as defined by incidence of death, inotrope requirements, arrhythmias, left ventricular dysfunction, pulmonary oedema or myocardial infarction
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): NCT00244283
|Contact: Martin F McCormick, MB ChB||44 141 951 5600||Martin.McCormick@gjnh.scot.nhs.uk|
|Contact: Stefan Schraag, MD PhD||44 141 951 5609||Stefan.Schraag@gjnh.scot.nhs.uk|
|Golden Jubilee National Hospital||Not yet recruiting|
|Glasgow, United Kingdom, G81 4HX|
|Contact: Martin F McCormick, MB ChB 44 141 951 5600 Martin.McCormick@gjnh.scot.nhs.uk|
|Contact: Stefan Schraag, MD PhD 44 141 951 5609 Stefan.Schraag@gjnh.scot.nhs.uk|
|Principal Investigator: Martin F McCormick, MB ChB|
|Sub-Investigator: Jorg Prinzlin|
|Study Director:||Stefan Schraag, MD PhD||Golden Jubilee National Hospital|
|Principal Investigator:||Martin F McCormick, MB ChB||Golden Jubilee National Hospital|