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临床试验/NCT00901394
NCT00901394已完成不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Change in Plasma Total Homocysteine Concentration (tHcy)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Treatment 1

Experimental

B12-Folic acid, nitrous oxide

干预措施: B12-Folic Acid, nitrous oxide (Drug)

Treatment 1

Experimental

B12-Folic acid, nitrous oxide

干预措施: Nitrous oxide (NO) and placebo (Drug)

Treatment 2

Active Comparator

Nitrous oxide (NO) and placebo

干预措施: Nitrous oxide (NO) and placebo (Drug)

Treatment 2

Active Comparator

Nitrous oxide (NO) and placebo

干预措施: Placebo (Other)

Control group

Placebo Comparator

oxygen nitrogen

干预措施: Placebo (Other)

Control group

Placebo Comparator

oxygen nitrogen

干预措施: oxygen nitrogen (Other)

结局指标

主要结局

Change in Plasma Total Homocysteine Concentration (tHcy)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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