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

Not Applicable

Completed

Interventions: Drug: B12-Folic Acid, nitrous oxide
Other: Placebo
Other: oxygen nitrogen
Drug: Nitrous oxide (NO) and placebo

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 cardiovascular complications.

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Plasma Total Homocysteine Concentration (tHcy)	Immediately postoperatively and on postoperative day 1	Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration . Of note: there were no secondary outcomes.

Secondary Outcome Measures