N/A N=63 Randomized Quadruple-blind Prevention

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

Cardiovascular Abnormalities

Bottom Line

View on ClinicalTrials.gov: NCT00901394 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Change in Plasma Total Homocysteine Concentration (tHcy) — 1.9; 2.7; 0.5 mcmol/L — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: B12-Folic Acid, nitrous oxide (Drug); Nitrous oxide (NO) and placebo (Drug); Placebo (Other); oxygen nitrogen (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Plasma Total Homocysteine Concentration (tHcy)	1.9; 2.7; 0.5	<0.05 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00901394). 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.