NCT00482456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
Last Updated

June 5, 2007

Status Verified

May 1, 2007

First QC Date

June 1, 2007

Last Update Submit

June 1, 2007

Conditions

Anesthesia, GeneralAdverse EffectsNitrous Oxide

Keywords

Nitrous oxideHomocysteinefolatevitamin B12

Outcome Measures

Primary Outcomes (1)

  • Homocysteine levels dependent on MTHFR genotype

    2 years

Interventions

Nitrous oxideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Medical University of Vienna

Vienna, A-1090, Austria

Location

Related Publications (2)

  • 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.

    PMID: 19339913DERIVED

  • 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.

    PMID: 18580170DERIVED

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Peter Nagele, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 5, 2007

Study Start

January 1, 2005

Study Completion

March 1, 2007

Last Updated

June 5, 2007

Record last verified: 2007-05

Locations

AU(1)