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Homocysteine After Nitrous Oxide Anesthesia

This study has been completed.

Sponsored by: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00482456
  Purpose

Our study looks at the interaction of a common mutation in the MTHFR gene and the risk of developing higher homocysteine levels after nitrous oxide (N2O) anesthesia.

Specifically, we want to test the hypothesis that healthy patients carrying the MTHFR 677C>T haplotype develop abnormal homocysteine levels after nitrous oxide anesthesia.


Condition Intervention Phase
Anesthesia, General
Adverse Effects
Nitrous Oxide
Drug: Nitrous oxide
Phase IV

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Folic acid    Vitamin B 12    Hydroxocobalamin    Homocysteine    Nitrous oxide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:   Influence of the MTHFR 677C>T Mutation on Homocysteine Levels After Nitrous Oxide Anesthesia.

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Homocysteine levels dependent on MTHFR genotype [ Time Frame: 2 years ]

Enrollment:   140
Study Start Date:   January 2005
Study Completion Date:   March 2007

Detailed Description:

Nitrous oxide – laughing gas – is a widely used anaesthetic gas with many favourable but also some dangerous properties. Among the latter is the increase in homocysteine levels after nitrous oxide (N2O) exposure by inhibition of enzymes in the vitamin B12 pathway. Elevated homocysteine levels have been found to be an independent risk factor for ischemic events and are associated with an increased risk for perioperative myocardial ischemia. If a patient carries one or more loss-of-function mutations in enzymes of the methionine/homocysteine/folate pathway he is at an increased risk for hyperhomocysteinemia and if exposed to N2O might suffer severe, sometimes disastrous neurological damage. Recently, a case report in the New England Journal of Medicine reported the death of a child with an enzyme defect in the MTHFR gene after anaesthesia with nitrous oxide (NEJM 2003;349:45-50).

Thus, we are convinced that if we can determine the risk of patients who carry mutations in the MTHFR gene and undergo anaesthesia with N2O for developing pathological levels of homocysteine, we can add an important piece of information to the safety profile of N2O.

Our study tests the hypothesis that patients who carry the 677C<T mutation in the MTHFR gene (the most common mutation) have a higher risk of developing hyperhomocysteinemia after N2O anaesthesia.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patient scheduled for general anaesthesia (> 2 hours)
  • Age > 18 years
  • ASA status I-II

Exclusion Criteria:

  • Pregnancy
  • Age < 18 years
  • contraindication against N2O: pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery
  • recent use of vitamin preps (B12, B6, folate)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482456

Locations
Austria
Dept of Anesthesiology, Medical University of Vienna    
      Vienna, Austria, A-1090

Sponsors and Collaborators
Medical University of Vienna

Investigators
Principal Investigator:     Peter Nagele, M.D.     Medical University of Vienna    
  More Information


Publications indexed to this study:

Study ID Numbers:   EK 286/2004
First Received:   June 1, 2007
Last Updated:   June 1, 2007
ClinicalTrials.gov Identifier:   NCT00482456
Health Authority:   Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Nitrous oxide  
Homocysteine  
folate  
vitamin B12  

Study placed in the following topic categories:
Folic Acid
Nitrous Oxide
Hydroxocobalamin
Vitamin B 12

Additional relevant MeSH terms:
Anesthetics, Inhalation
Anesthetics, General
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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