Coronary Artery Disease Clinical Trial
Official title:
Large, Randomised, Parallel-group, Controlled Trial, With Patients Randomly Allocated to Either N2O-containing (70% N2O in Oxygen [FiO2 0.3]) or N2O-free (70% Nitrogen in Oxygen [FiO2 0.3]).
To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.
Approximately 25% of patients undergoing major surgery have known coronary artery disease
(CAD) or risk factors for CAD.
N2O interferes with vitamin B12 and folate metabolism. This impairs production of methionine
(from homocysteine), used to form tetrahydrofolate and thymidine during DNA synthesis. It has
been repeatedly demonstrated that N2O anaesthesia increases postoperative homocysteine
levels. Chronic hyperhomocysteinaemia is associated with cardiovascular disease, and acute
hyperhomocysteinaemia is known to cause endothelial dysfunction. One small trial has
demonstrated an increased incidence of postoperative myocardial ischaemia in patients
receiving N2O anaesthesia. Reducing postoperative myocardial infarction and death are
important aims for those with CAD undergoing major surgery.
Our previous trial (ENIGMA) studied 2050 patients and identified some serious adverse
effects, but most patients were not at risk of CAD and so we could not reliably assess
serious cardiac complications. We propose a large simple randomized clinical trial of 7,000
patients to provide a definitive evaluation of the safety of N2O anaesthesia.
Updated statistical analysis plan can be found at www.enigma2.org.au.
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