Vitamins in Nitrous Oxide Study

Completed · Not applicable · Has a placebo group

Conditions studied: Major Surgery, Coronary Artery Disease

In brief

In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of cardiac complications after surgery in patients with a specific genetic profile (mutations in the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate during surgery.

Key facts

Study ID

NCT00655980

Run by

Washington University School of Medicine

People needed

687

Starts

2008-02-01

Expected to finish

2016-12-01

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patients not expected to live past 24 hours (ASA 5)
• Patients with significant pulmonary disease requiring supplemental oxygen
• Patients taking supplemental vitamin B12 or folate
• Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)
• Hypersensitivity to cobalamins
• Leber's disease (hereditary optic nerve atrophy) [vitamin B12 interaction]
• Seizure disorder [folate interference]

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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