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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Anesthesia Education and Research
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00901394
First received: May 8, 2009
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
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 Intervention
Cardiovascular Abnormalities
Drug: B12-Folic Acid, nitrous oxide
Drug: Nitrous oxide (NO) and placebo
Other: Placebo
Other: oxygen nitrogen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

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

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

Enrollment: 577
Study Start Date: March 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00901394     History of Changes
Other Study ID Numbers: 09-0074
Study First Received: May 8, 2009
Last Updated: April 26, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017