Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia (Mini-VINO)

This study has been completed.

Sponsor:

Collaborator:

Foundation for Anesthesia Education and Research

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00901394

First received: May 8, 2009

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2009

Last Updated Date

May 30, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postoperative plasma total homocysteine concentrations (tHcy) [ Time Frame: Immediately postoperatively and on postoperative day 1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00901394 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Association of MTHFR 677C>T genotype on tHcy increase [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cardiovascular Abnormalities

Intervention ^ICMJE

Drug: B-vitamins
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.
Drug: Nitrous oxide (NO)
60% nitrous oxide anesthesia
Drug: Placebo
Placebo: only 250 ml normal saline, no B-vitamins
Drug: Placebo nitrous oxide
NO nitrous oxide (60% air and oxygen mix).

Study Arm (s)

Experimental: 1
Patients receive IV B-vitamins (1mg vitamin B12 and 5 mg folic acid diluted in 250 ml normal saline infusion) plus 60% nitrous oxide anesthesia
Interventions:
- Drug: B-vitamins
- Drug: Nitrous oxide (NO)
Placebo Comparator: 2
Patients receive placebo (250 ml normal saline infusion) plus 60% nitrous oxide anesthesia
Interventions:
- Drug: Nitrous oxide (NO)
- Drug: Placebo
Placebo Comparator: 3
Patients receive placebo (250 ml normal saline infusion) but NO nitrous oxide (60% air and oxygen mix).
Interventions:
- Drug: Placebo
- Drug: Placebo nitrous oxide

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

577

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00901394

Other Study ID Numbers ^ICMJE

09-0074

Has Data Monitoring Committee

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Foundation for Anesthesia Education and Research

Investigators ^ICMJE

Principal Investigator:

Peter Nagele, MD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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