A Comparison of Two Anaesthetic Methods of Protecting Heart Tissue During Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Golden Jubilee National Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
European Society for Intravenous Anaesthesia
Information provided by:
Golden Jubilee National Hospital
ClinicalTrials.gov Identifier:
NCT00244283
First received: October 24, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

To compare two different methods of protecting heart muscle from damage caused by a decreased blood supply. Exposure to the anaesthetic agent sevoflurane can allow the heart muscle to resist longer periods of low blood or oxygen supply without sustaining the amount of damage that it would otherwise expect to. The use of thoracic epidural analgesia improves the blood flow to the heart muscle and has also been shown to reduce the amount of damage the heart muscle may otherwise sustain. The aim of this study is to compare these two methods.


Condition Intervention Phase
Coronary Artery Bypass Surgery
Drug: Sevoflurane
Procedure: High thoracic epidural analgesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of Myocardial Protection Using Preconditioning With Sevoflurane Against High Thoracic Epidural Analgesia for CABG Surgery

Resource links provided by NLM:


Further study details as provided by Golden Jubilee National Hospital:

Primary Outcome Measures:
  • Plasma concentration of NT-proBNP as a biochemical marker of ventricular dysfunction

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
Detailed Description:

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.

Comparison:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting for elective CABG operations, with >40 % left ventricular ejection fraction, aged 40-80.

Exclusion Criteria:

  • Patients at risk of epidural haematomas (i.e. platelets <100, coagulopathies, on anticoagulant therapies, INR>1.4) or unsuited to HTEA (patient refusal, spinal deformities).

Patients on drugs shown to manipulate the preconditioning phenomenon will also be excluded. This includes those on diazoxide, nicorandil, oral sulfonylureas and theophyllines.

Patients with preoperative ECG morphologies likely to make interpretation difficult or impossible including: left bundle branch block, cardiac pacemaker dependence.

Haemodynamically compromised patients requiring inotropic or balloon pump support preoperatively.

Significant valvular disease. Preoperative elevated levels of troponin I or CKMB. Unstable angina or angina in 24 hours preop

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244283

Contacts
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

Locations
United Kingdom
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         
Sponsors and Collaborators
Golden Jubilee National Hospital
European Society for Intravenous Anaesthesia
Investigators
Study Director: Stefan Schraag, MD PhD Golden Jubilee National Hospital
Principal Investigator: Martin F McCormick, MB ChB Golden Jubilee National Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00244283     History of Changes
Other Study ID Numbers: gjnh/mccormick/01, EUDRACT no. 2005-004398-76
Study First Received: October 24, 2005
Last Updated: October 24, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Golden Jubilee National Hospital:
Myocardial preconditioning
anesthetics
epidural anesthesia
sevoflurane
NT proBNP

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on April 23, 2014