CompletedPhase 4

The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial

Australia7,112 participantsStarted 2007-04

Plain-language summary

To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult males and females age ≥ 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
✓. At increased risk of cardiac events, defined as any of
✓. history of coronary artery disease as defined by a history of any one of the following: i. angina ii. MI iii. segmental wall motion abnormality on echocardiography or a fixed defect on radionuclide imaging iv. a positive exercise stress test for cardiac ischaemia v. a positive radionuclide exercise, echocardiographic exercise, or pharmacological cardiovascular stress test for cardiac ischaemia vi. coronary revascularization (CABG or PTCA) vii. angiographic evidence of atherosclerotic stenosis \> 50% of the diameter of any coronary artery viii. ECG with pathological Q waves in two contiguous leads
✓. heart failure
✓. cerebrovascular disease thought due to atherothrombotic disease
✓. aortic or peripheral vascular disease
✓. or three or more of the following risk factors:

Exclusion criteria

✕. having cardiac surgery
✕. marked impairment of gas-exchange expected to require Fi02\> 0.5 intraoperatively
✕. specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
✕. N2O unavailable for use.

What they're measuring

The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery.

Timeframe: 30 days post op

Trial details

NCT IDNCT00430989

SponsorBayside Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2016-02-16

View on ClinicalTrials.gov More Coronary Artery Disease trials