A comparison of Myocardial Protection Using Preconditioning with Sevoflurane Against High Thoracic Epidural Analgesia for CABG Surgery

• Conditions: Ischaemic heart disease

• Registration Number: EUCTR2005-004398-76-GB
• Lead Sponsor: Golden Jubilee National Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-20
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients presenting for elective CABG operations, with >40 % left ventricular ejection fraction, aged 40-80.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare two anaesthetic techniques to protect myocardial tissue from damage during cardiac surgery. ;Secondary Objective: ;Primary end point(s): Plasma concentrations of the N-terminal pro brain natriuretic peptide (NT-proBNP) as a biochemical marker of ventricular dysfunction. <br>Cardiac morbidity/ mortality as defined by incidence of death, inotrope requirements, arrhythmias, left ventricular dysfunction, pulmonary oedema or myocardial infarction.<br>Biochemical markers of myocardial damage, namely troponin I and creatine kinase MB<br>ECG evidence of myocardial damage or ischaemia<br>