Influence of Preoperative 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: May 30, 2012
Last verified: May 2012
  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: B-vitamins
Drug: Nitrous oxide (NO)
Drug: Placebo
Drug: Placebo nitrous oxide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of MTHFR 677C>T genotype on tHcy increase [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 577
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receive IV B-vitamins (1mg vitamin B12 and 5 mg folic acid diluted in 250 ml normal saline infusion) plus 60% nitrous oxide anesthesia
Drug: B-vitamins

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.

Drug: Nitrous oxide (NO)
60% nitrous oxide anesthesia
Placebo Comparator: 2
Patients receive placebo (250 ml normal saline infusion) plus 60% nitrous oxide anesthesia
Drug: Nitrous oxide (NO)
60% nitrous oxide anesthesia
Drug: Placebo
Placebo: only 250 ml normal saline, no B-vitamins
Placebo Comparator: 3
Patients receive placebo (250 ml normal saline infusion) but NO nitrous oxide (60% air and oxygen mix).
Drug: Placebo
Placebo: only 250 ml normal saline, no B-vitamins
Drug: Placebo nitrous oxide
NO nitrous oxide (60% air and oxygen mix).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
St. 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 Early Recognition Center
  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: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Nitrous oxide
cobalamin
homocysteine
vitamin B12
folate
No specific diseases targeted
Focus is on all patients receiving general anesthesia with nitrous oxide for elective surgery

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

ClinicalTrials.gov processed this record on August 01, 2014