Laughing gas under the microscope: is it safe for heart patients?
NCT ID NCT00430989
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether nitrous oxide (laughing gas) is safe for people with heart disease risk factors who need major surgery. Over 7,000 adults aged 45 and older were randomly assigned to receive either nitrous oxide or a gas without it during anesthesia. The researchers tracked deaths and heart-related problems like heart attack, stroke, and heart failure for 30 days after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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7,112 people
The number who actually took part.
- Start date
-
Apr 2007
- Finished
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Sep 2013
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Adult males and females age ≥ 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours. 2. At increased risk of cardiac events, defined as any of 1. 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 2. heart failure 3. cerebrovascular disease thought due to atherothrombotic disease 4. aortic or peripheral vascular disease 5. 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 1. having cardiac surgery 2. marked impairment of gas-exchange expected to require Fi02\> 0.5 intraoperatively 3. specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery) 4. N2O unavailable for use.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alfred Hosptial
Melbourne, Victoria, 3004, Australia
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Other studies related to the condition(s) this trial covers.
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