Vitamins in Nitrous Oxide Study

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Foundation for Anesthesia Education and Research; National Institute of General Medical Sciences (NIGMS)
• Treatments: Folic Acid; Hydroxocobalamin; Nitrous Oxide; Vitamin B 12; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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]