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Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia (Mini-VINO)

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ClinicalTrials.gov Identifier: NCT00901394
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Foundation for Anesthesia Education and Research
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Abnormalities Drug: B12-Folic Acid, nitrous oxide Drug: Nitrous oxide (NO) and placebo Other: Placebo Other: oxygen nitrogen Not Applicable

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 24, 48, and 72 hours after surgery. We will be checking their troponin I and troponin T, homocysteine, Vitamin B12, and folate levels. We will also take a blood sample to determine their MTHFR genotype and 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. We would like to run a NT-ProBNP biomarker test on the samples.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
Study Start Date : March 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: Treatment 1
B12-Folic acid, nitrous oxide
Drug: B12-Folic Acid, nitrous oxide

IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.

IV folic acid, 5 mg, single administration over 30 min.

Both diluted in 250 ml normal saline.

Other Name: b supplements

Drug: Nitrous oxide (NO) and placebo
60% nitrous oxide anesthesia plus saline
Other Name: nitrous oxide

Active Comparator: Treatment 2
Nitrous oxide (NO) and placebo
Drug: Nitrous oxide (NO) and placebo
60% nitrous oxide anesthesia plus saline
Other Name: nitrous oxide

Other: Placebo
Saline
Other Name: saline

Placebo Comparator: Control group
oxygen nitrogen
Other: Placebo
Saline
Other Name: saline

Other: oxygen nitrogen
60% air and oxygen mix.
Other Name: air




Primary Outcome Measures :
  1. Postoperative plasma total homocysteine concentrations (tHcy) [ Time Frame: Immediately postoperatively and on postoperative day 1 ]

Secondary Outcome Measures :
  1. Association of MTHFR 677C>T genotype on tHcy increase [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901394


Locations
United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Foundation for Anesthesia Education and Research
Investigators
Principal Investigator: Peter Nagele, MD Washington University School of Medicine

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00901394     History of Changes
Other Study ID Numbers: 09-0074
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
Nitrous oxide
cobalamin
homocysteine
vitamin B12
folate
No specific diseases targeted

Additional relevant MeSH terms:
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Anesthetics
Nitrous Oxide
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Central Nervous System Depressants
Hematinics
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents