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Completed

NCT Number: NCT00482456

Homocysteine After Nitrous Oxide Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept of Anesthesiology, Medical University of Vienna

Vienna, A-1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nitrous Oxide

Drug

Primary outcomes

  1. Homocysteine levels dependent on MTHFR genotype

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Influence of the MTHFR 677C>T Mutation on Homocysteine Levels After Nitrous Oxide Anesthesia.

Important dates

Study start
2005
Study completion
2007
First posted
Jun 5, 2007
Registry last updated
Jun 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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