Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia

NCT00901394 | Completed Results

• 1 other identifier: 09-0074
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Abnormalities

Keywords

Nitrous oxide; cobalamin; homocysteine; vitamin B12; folate; No specific diseases targeted

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Treatment 1

EXPERIMENTAL

B12-Folic acid, nitrous oxide

Drug: B12-Folic Acid, nitrous oxide; Drug: Nitrous oxide (NO) and placebo

Treatment 2

ACTIVE COMPARATOR

Nitrous oxide (NO) and placebo

Drug: Nitrous oxide (NO) and placebo; Other: Placebo

Control group

PLACEBO COMPARATOR

oxygen nitrogen

Other: Placebo; Other: oxygen nitrogen

Interventions

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.

Also known as: b supplements

Treatment 1

Nitrous oxide (NO) and placebo DRUG

60% nitrous oxide anesthesia plus saline

Also known as: nitrous oxide

Treatment 1; Treatment 2

Placebo OTHER

Saline

Also known as: saline

Control group; Treatment 2

oxygen nitrogen OTHER

60% air and oxygen mix.

Also known as: air

Control group

Eligibility Criteria

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

You may qualify if:

• Adult patients scheduled for elective surgery with expected duration \> 2 hours
• Healthy patients undergoing moderate surgery where the use of N2O is unproblematic

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Foundation for Anesthesia Education and Research: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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: 18580170 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.

  PMID: 19339913 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.

  PMID: 18813045 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

Nitrous Oxide; Sodium Chloride; nitrox; Air

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Chicago

7737022544

Study Officials

• Peter Nagele, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 13, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)