Vitamins in Nitrous Oxide Study

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

It had three arms (groups): Treatment (experimental), Comparator (placebo comparator) and Standard of care (other).

Vitamin B12 and folic acid.

Nitrous oxide and placebo.

Standard of care.

The registry classes the interventions as drug and other.

More on the Plan

Homocysteine has been identified as risk factor for cardiovascular disease.

Therefore elevations in homocysteine after N2O may be a causative factor in N2O toxicity.

These patients might be at higher risk for adverse cardiac outcomes from N2O.

Primary outcome: Myocardial ischemia in the first 72 hours after surgery (measured by serial troponin and ECGs).

Who Took Part

687 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients; age \>18 yrs, ASA III-IV. Previously diagnosed coronary artery disease or at risk for coronary artery disease. Scheduled for major surgery (\>2 hrs).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients not expected to live past 24 hours (asa 5); patients taking supplemental vitamin b12 or folate; contraindication against n2o (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure).

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-02 with completion listed for 2016-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Myocardial Ischemia (time frame: first 3 postoperative days).

It also tracked 1 secondary outcome, for example Non-fatal MI.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 687 people.

With 687 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.