Status:
COMPLETED
The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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:
- age ≥70 years
- any history of congestive heart failure
- diabetes and currently on an oral hypoglycaemic agent or insulin therapy
- current treatment for hypertension
- preoperative serum creatinine \>175 micro mol/L (\> 2.0 mg/dl)
- current or previous high cholesterol ≥6.2 mmol/L (\> 240 mg/dl)
- history of a transient ischemic attack (TIA) (i.e. a transient focal neurological deficit that lasted less than 24 hours and thought to be vascular in origin)
- emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital)
- high-risk type of surgery (i.e. intrathoracic or intraperitoneal)
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
7112 Patients enrolled
Trial Details
Trial ID
NCT00430989
Start Date
April 1 2007
End Date
September 1 2013
Last Update
December 4 2019
Active Locations (1)
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1
Alfred Hosptial
Melbourne, Victoria, Australia, 3004