Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
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
- 否
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
B12-Folic acid, nitrous oxide
干预措施: B12-Folic Acid, nitrous oxide (Drug)
Treatment 1
B12-Folic acid, nitrous oxide
干预措施: Nitrous oxide (NO) and placebo (Drug)
Treatment 2
Nitrous oxide (NO) and placebo
干预措施: Nitrous oxide (NO) and placebo (Drug)
Treatment 2
Nitrous oxide (NO) and placebo
干预措施: Placebo (Other)
Control group
oxygen nitrogen
干预措施: Placebo (Other)
Control group
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
