Cardiovascular Abnormalities Clinical Trial
Official title:
Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
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.
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 folate, 5 mg) before
surgery.
- Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery
and placebo before and after surgery.
- Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before
surgery. Patients in this arm will not be randomized.
Patients will have blood drawn (total of 1-2 teaspoons over 3 days). We will take these
samples before their surgery, when their surgery is completed, and in the morning of
post-operative day 1. We will be checking their troponin I and troponin T, homocysteine,
Vitamin B12, and folate levels. We will also perform a 12-lead EKG. Before and after surgery
for patients in Arm A or B, will receive either vitamin B12 (1 mg) and folic acid (5 mg) (or
placebo) added to their IV infusion. We also plan to use a non-invasive test known as a nerve
conduction study to measure the function of their nerve system. Briefly, 2 small electrodes
are attached to their skin over a nerve and, like an EKG, faint electrical pulses are
generated and recorded. A typical nerve conduction measurement lasts about 10 minutes.
After the patients surgery we will do genetic testing of MTHFR genotype.
All study samples have been collected.
Of note: there were no secondary outcomes.
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