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CompletedNCT00482456Updated Jun 5, 2007

Homocysteine After Nitrous Oxide Anesthesia

A Phase 4 interventional study of Nitrous oxide in Anesthesia, General, Adverse Effects and Nitrous Oxide, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-06-05.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Anesthesia, General
  • Adverse Effects
  • Nitrous Oxide

Keywords

  • Nitrous oxide
  • Homocysteine
  • folate
  • vitamin B12
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Homocysteine levels dependent on MTHFR genotype

    Time frame: 2 years

07

Study locations

1 site
  • Dept of Anesthesiology, Medical University of Vienna
    Vienna, A-1090, Austria
08

References and documents

Publications

  • Nagele P, Zeugswetter B, Eberle C, Hupfl M, Mittlbock M, Fodinger M. A common gene variant in methionine synthase reductase is not associated with peak homocysteine concentrations after nitrous oxide anesthesia. Pharmacogenet Genomics. 2009 May;19(5):325-9. doi: 10.1097/FPC.0b013e328328d54c. PubMed 19339913 ↗
  • Nagele P, Zeugswetter B, Wiener C, Burger H, Hupfl M, Mittlbock M, Fodinger M. Influence of methylenetetrahydrofolate reductase gene polymorphisms on homocysteine concentrations after nitrous oxide anesthesia. Anesthesiology. 2008 Jul;109(1):36-43. doi: 10.1097/ALN.0b013e318178820b. PubMed 18580170 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00482456
First posted
Jun 5, 2007
Start date
Jan 2005
Completion
Mar 2007
Last update
Jun 5, 2007

Study contacts

Peter Nagele, M.D.
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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