Vitamins in Nitrous Oxide Study

NCT00655980 | Completed Results DMC

• 1 other identifier: HSC 07-0592
• Study Type: interventional
• Target: 687
• Locations: 1 country
• Sites: 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.

Conditions

Major Surgery; Coronary Artery Disease

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

EXPERIMENTAL

Vitamin B12 and folic acid

Drug: Vitamin B12 and folic acid

Comparator

PLACEBO COMPARATOR

Nitrous oxide and placebo

Drug: Nitrous oxide and placebo

Standard of care

OTHER

standard of care

Other: standard of care

Interventions

Vitamin B12 and folic acid DRUG

1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion

Treatment

Nitrous oxide and placebo DRUG

Comparator

standard of care OTHER

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[folate interference\]

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• Foundation for Anesthesia Education and Research: collaborator

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Vitamin B 12; Folic Acid; Nitrous Oxide; Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Chicago Medicine

7737022544

Study Officials

• Peter Nagele, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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

Locations

US (1)