Status:
COMPLETED
Vitamins in Nitrous Oxide Study
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Foundation for Anesthesia Education and Research
Conditions:
Major Surgery
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 gen...
Detailed Description
Background and significance: Recent studies have shown that nitrous oxide (N2O) anesthesia may be associated with an increased risk of adverse cardiovascular outcomes. It is well-known that N2O inhibi...
Eligibility Criteria
Inclusion
- 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
- 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 \[folate interference\]
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
687 Patients enrolled
Trial Details
Trial ID
NCT00655980
Start Date
February 1 2008
End Date
December 1 2016
Last Update
October 1 2020
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110