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临床试验/NCT00482456
NCT00482456已完成4 期

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

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Homocysteine levels dependent on MTHFR genotype

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Homocysteine levels dependent on MTHFR genotype

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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