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Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia

NCT00901394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-09-16

Study results available
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Summary

The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.

Conditions

  • Cardiovascular Abnormalities

Interventions

DRUG

B12-Folic Acid, nitrous oxide

IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min. IV folic acid, 5 mg, single administration over 30 min. Both diluted in 250 ml normal saline.

DRUG

Nitrous oxide (NO) and placebo

60% nitrous oxide anesthesia plus saline

OTHER

Placebo

Saline

OTHER

oxygen nitrogen

60% air and oxygen mix.

Sponsors & Collaborators

  • 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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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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 NCT00901394 on ClinicalTrials.gov