Cardiovascular AbnormalitiesMini-VINONCT00901394
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
A study testing B12-Folic Acid, nitrous oxide and oxygen nitrogen in people with Cardiovascular Abnormalities, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Abnormalities
- What is being tested?
- B12-Folic Acid, nitrous oxide and oxygen nitrogen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective surgery with expected duration > 2 hours
- Healthy patients undergoing moderate surgery where the use of N2O is unproblematic
Who cannot join
- Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)
- Patients requiring supplemental oxygen
- Urgent or emergent surgery
- Patients with vitamin B12 or folate deficiency or megaloblastic anemia
- Patients with seizure disorder (epilepsy)
- Allergy or hypersensitivity against IV cobalamin or folate
- Patients with Leber's disease (hereditary optic nerve atrophy)
- Patients taking supplemental vitamin B12 or folate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
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.
Read the detailed description
Patients will be randomized into the following arms:
- Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery.
- Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery and placebo before and after surgery.
- Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before surgery. Patients in this arm will not be randomized.
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.
- Conditions
- Cardiovascular Abnormalities
- Being tested
- B12-Folic Acid, nitrous oxide, Nitrous oxide (NO) and placebo, Placebo, oxygen nitrogen
- Keywords
- Nitrous oxide, cobalamin, homocysteine, vitamin B12, folate, No specific diseases targeted
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B12-Folic Acid, nitrous oxideDrug
Also called b supplements
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.
Nitrous oxide (NO) and placeboDrug
Also called nitrous oxide
60% nitrous oxide anesthesia plus saline
PlaceboOther
Also called saline
Saline
oxygen nitrogenOther
Also called air
60% air and oxygen mix.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | B12-Folic acid, nitrous oxide Receives: Drug: B12-Folic Acid, nitrous oxide; Drug: Nitrous oxide (NO) and placebo |
| Treatment 2 | Active comparator | Nitrous oxide (NO) and placebo Receives: Drug: Nitrous oxide (NO) and placebo; Other: Placebo |
| Control group | Placebo comparator | oxygen nitrogen Receives: Other: Placebo; Other: oxygen nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately postoperatively and on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research
- Responsible party
- Sponsor
- Investigators
- Peter Nagele, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901394
- Sponsor's protocol ID
- 09-0074
- Acronym
- Mini-VINO
- Status last verified
- Aug 2020
- First submitted
- 8 May 2009
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18580170Nagele 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.
PubMed 19339913Myles 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.
PubMed 18813045
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
- ClinicalTrials.gov ID
- NCT00901394
- Acronym / sponsor ID
- Mini-VINO / 09-0074
- Conditions
- Cardiovascular Abnormalities
- Keywords
- Nitrous oxide, cobalamin, homocysteine, vitamin B12, folate, No specific diseases targeted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be randomized into the following arms:
- Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery.
- Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery and placebo before and after surgery.
- Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before surgery. Patients in this arm will not be randomized.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: B12-Folic Acid, nitrous oxide, Drug: Nitrous oxide (NO) and placeboB12-Folic acid, nitrous oxide |
| Treatment 2 | Active comparator | Drug: Nitrous oxide (NO) and placebo, Other: PlaceboNitrous oxide (NO) and placebo |
| Control group | Placebo comparator | Other: Placebo, Other: oxygen nitrogenoxygen nitrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients scheduled for elective surgery with expected duration > 2 hours
- Healthy patients undergoing moderate surgery where the use of N2O is unproblematic
Key exclusion criteria (8 listed)
- Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)
- Patients requiring supplemental oxygen
- Urgent or emergent surgery
- Patients with vitamin B12 or folate deficiency or megaloblastic anemia
- Patients with seizure disorder (epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B12-Folic Acid, nitrous oxideAlso: b supplementsIV 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. | Drug | Treatment 1 |
| Nitrous oxide (NO) and placeboAlso: nitrous oxide60% nitrous oxide anesthesia plus saline | Drug | Treatment 1, Treatment 2 |
| PlaceboAlso: salineSaline | Other | Control group, Treatment 2 |
| oxygen nitrogenAlso: air60% air and oxygen mix. | Other | Control group |
Primary outcome
Change in Plasma Total Homocysteine Concentration (tHcy)
Time frame: Immediately postoperatively and on postoperative day 1
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18580170Nagele 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.
- Background: PubMed 19339913Nagele 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.
- Background: PubMed 18813045Myles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nagele, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B12-Folic Acid, nitrous oxide and oxygen nitrogen in people with Cardiovascular Abnormalities, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Total Homocysteine Concentration (tHcy) (time frame: Immediately postoperatively and on postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901394, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.