N/A
Completed N=687
Vitamins in Nitrous Oxide Study
Major Surgery · Coronary Artery Disease
Source: ClinicalTrials.gov NCT00655980 ↗
Enrolled (actual)
687
Serious AEs
0.6%
Results posted
Oct 2020
Primary outcomePrimary: Myocardial Ischemia — 33; 34; 17; 217 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Ischemia |
33; 34; 17; 217; 216; 108 | — |
| SECONDARY Non-fatal MI |
7; 15; 8 | — |
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. Informational only — not medical advice.