CompletedNot Applicable

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

United States63 participantsStarted 2009-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients scheduled for elective surgery with expected duration \> 2 hours * Healthy patients undergoing moderate surgery where the use of N2O is unproblematic Exclusion Criteria: * Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure) * Patients requiring supplemental oxygen * Urgent or emergent surgery * Patients with vitamin B12 or folate deficiency or megaloblastic anemia * Patients with seizure disorder (epilepsy) * Allergy or hypersensitivity against IV cobalamin or folate * Patients with Leber's disease (hereditary optic nerve atrophy) * Patients taking supplemental vitamin B12 or folate

What they're measuring

Change in Plasma Total Homocysteine Concentration (tHcy)

Timeframe: Immediately postoperatively and on postoperative day 1

Trial details

NCT IDNCT00901394

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2018-04-23

View on ClinicalTrials.gov More Cardiovascular Abnormalities trials