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| Name | Class |
|---|---|
| Foundation for Anesthesia Education and Research | OTHER |
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The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.
Patients will be randomized into the following arms:
Patients will have blood drawn (total of 1-2 teaspoons over 3 days). We will take these samples before their surgery, when their surgery is completed, and in the morning of post-operative day 1. We will be checking their troponin I and troponin T, homocysteine, Vitamin B12, and folate levels. We will also perform a 12-lead EKG. Before and after surgery for patients in Arm A or B, will receive either vitamin B12 (1 mg) and folic acid (5 mg) (or placebo) added to their IV infusion. We also plan to use a non-invasive test known as a nerve conduction study to measure the function of their nerve system. Briefly, 2 small electrodes are attached to their skin over a nerve and, like an EKG, faint electrical pulses are generated and recorded. A typical nerve conduction measurement lasts about 10 minutes.
After the patients surgery we will do genetic testing of MTHFR genotype.
All study samples have been collected.
Of note: there were no secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | B12-Folic acid, nitrous oxide |
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| Treatment 2 | Active Comparator | Nitrous oxide (NO) and placebo |
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| Control group | Placebo Comparator | oxygen nitrogen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B12-Folic Acid, nitrous oxide | Drug | IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min. IV folic acid, 5 mg, single administration over 30 min. Both diluted in 250 ml normal saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Total Homocysteine Concentration (tHcy) | Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration . Of note: there were no secondary outcomes. | Immediately postoperatively and on postoperative day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Nagele, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18580170 | Background | 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. | |
| 19339913 | Background | 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. |
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63 patients were consented however only 59 were analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | B-vitamins Plus Nitrous Oxide | IV vitamin B12 (cyanocobalamin) 1 mg, IV folic acid, 5 mg, 60% nitrous oxide |
| FG001 | Nitrous Oxide Plus Placebo | 60% nitrous oxide Placebo: normal saline (no vitamins) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Nitrous oxide (NO) and placebo | Drug | 60% nitrous oxide anesthesia plus saline |
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| Placebo | Other | Saline |
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| oxygen nitrogen | Other | 60% air and oxygen mix. |
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| 18813045 | Background | Myles PS, Chan MT, Kaye DM, McIlroy DR, Lau CW, Symons JA, Chen S. Effect of nitrous oxide anesthesia on plasma homocysteine and endothelial function. Anesthesiology. 2008 Oct;109(4):657-63. doi: 10.1097/ALN.0b013e31818629db. |
| FG002 | Nitrous Oxide-free Group Plus Placebo | No nitrous oxide during anesthesia (oxygen/nitrogen) Placebo: normal saline |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | B-vitamins Plus Nitrous Oxide | |
| BG001 | Nitrous Oxide Plus Placebo | |
| BG002 | Nitrous Oxide-free Group Plus Placebo | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma Total Homocysteine Concentration (tHcy) | Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration . Of note: there were no secondary outcomes. | Posted | Median | 95% Confidence Interval | mcmol/L | Immediately postoperatively and on postoperative day 1 |
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AEs were assessed only in the immediate study period (surgery to postoperative day 1)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B-vitamins Plus Nitrous Oxide | 0 | 20 | 0 | 20 | 0 | 20 | |
| EG001 | Nitrous Oxide Plus Placebo | 0 | 19 | 0 | 19 | 2 | 19 | |
| EG002 | Nitrous Oxide-free Group Plus Placebo | 0 | 20 | 0 | 20 | 1 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PONV | Nervous system disorders | Non-systematic Assessment | Postopertaive nausea and vomiting |
| |
| Postop. cardiac troponin elevation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Chicago | 7737022544 |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D012965 | Sodium Chloride |
| C041364 | nitrox |
| D000388 | Air |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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| Male |
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