Status:
COMPLETED
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Foundation for Anesthesia Education and Research
Conditions:
Cardiovascular Abnormalities
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cardiova...
Detailed Description
Patients will be randomized into the following arms: * Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and fo...
Eligibility Criteria
Inclusion
- Adult patients scheduled for elective surgery with expected duration \> 2 hours
- Healthy patients undergoing moderate surgery where the use of N2O is unproblematic
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00901394
Start Date
March 1 2009
End Date
January 1 2010
Last Update
September 16 2020
Active Locations (1)
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1
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110