Vitamins in Nitrous Oxide Study
VINO
Pharmacogenetics of Adverse Outcomes After Nitrous Oxide Anesthesia
1 other identifier
interventional
687
1 country
1
Brief Summary
In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of cardiac complications after surgery in patients with a specific genetic profile (mutations in the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
October 1, 2020
CompletedOctober 1, 2020
September 1, 2020
8.8 years
April 4, 2008
April 23, 2018
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial Ischemia
Measured by serial troponin and ECG
first 3 postoperative days
Secondary Outcomes (1)
Non-fatal MI
30 day postoperative
Study Arms (3)
Treatment
EXPERIMENTALVitamin B12 and folic acid
Comparator
PLACEBO COMPARATORNitrous oxide and placebo
Standard of care
OTHERstandard of care
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients; age \>18 yrs, ASA III-IV
- Previously diagnosed coronary artery disease or at risk for coronary artery disease
- Scheduled for major surgery (\>2 hrs)
You may not qualify if:
- Patients not expected to live past 24 hours (ASA 5)
- Patients with significant pulmonary disease requiring supplemental oxygen
- Patients taking supplemental vitamin B12 or folate
- Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)
- Hypersensitivity to cobalamins
- Leber's disease (hereditary optic nerve atrophy) \[vitamin B12 interaction\]
- Seizure disorder \[folate interference\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- University of Chicago Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Nagele, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 10, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 1, 2020
Results First Posted
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share