N/A
N=687
Vitamins in Nitrous Oxide Study
Major Surgery · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00655980 ↗Enrolled (actual)
687
Serious AEs
0.6%
Results posted
Oct 2020
Primary outcome: Primary: Myocardial Ischemia — 33; 34; 17; 217 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin B12 and folic acid (Drug); Nitrous oxide and placebo (Drug); standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Ischemia |
33; 34; 17; 217; 216; 108 | — |
| SECONDARY Non-fatal MI |
7; 15; 8 | — |
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.
Eligibility 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]
Data sourced from ClinicalTrials.gov (NCT00655980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.