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Vitamins in Nitrous Oxide Study

NCT00655980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2020-10-01

Study results available
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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.

Conditions

Interventions

DRUG

Vitamin B12 and folic acid

1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion

DRUG

Nitrous oxide and placebo

OTHER

standard of care

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Foundation for Anesthesia Education and Research

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Peter Nagele, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655980 on ClinicalTrials.gov