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Laughing gas under the microscope: is it safe for heart patients?

NCT ID NCT00430989

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

7,112 people

The number who actually took part.

Start date

Apr 2007

Finished

Sep 2013

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Alfred Hosptial

    Melbourne, Victoria, 3004, Australia

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