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Sponsored by: |
Medical University of Vienna |
Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00482456 |
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 |
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. |
Enrollment: | 140 |
Study Start Date: | January 2005 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |||||
Dept of Anesthesiology, Medical University of Vienna | |||||
Vienna, Austria, A-1090 |
Medical University of Vienna |
Principal Investigator: | Peter Nagele, M.D. | Medical University of Vienna |
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 |
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