Homocysteine After Nitrous Oxide Anesthesia

Phase 4

Completed

• Conditions: Anesthesia, General; Adverse Effects; Nitrous Oxide

• Registration Number: NCT00482456
• Lead Sponsor: Medical University of Vienna

Brief 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.

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.

Study Timeline

• Study Start: 2005-01
• Study Completion: 2007-03
• Status Verified: 2007-05
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Last Update Submitted: 2007-06-01
• Study First Posted: 2007-06-05
• Last Update Posted: 2007-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Homocysteine levels dependent on MTHFR genotype	2 years

Trial Locations

Locations (1)

Dept of Anesthesiology, Medical University of Vienna; 🇦🇹 Vienna, Austria