Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients

Last updated: July 28, 2021
Sponsor: Xijing Hospital
Overall Status: Terminated

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Mental Disability

Treatment

N/A

Clinical Study ID

NCT03485404
KY20172057-1
  • Ages > 65
  • All Genders

Study Summary

This study will recruit patients more than 65 years old eligible for non-cardiac surgery. Patients who participate will take either vitamin B12 and folic acid supplementation or placebo for 7 days before surgery. Neuropsychological test battery (NPB) will be tested before intervention and at discharge for determination of Post operative cognitive dysfunction (POCD). Another group of non-surgical elderly participants will also be tested for NPB to account for learning effect in POCD diagnosis. The hypothesis is that preoperative vitamin B12 supplementation will reduce the incidence of POCD in elderly patients undergoing non-cardiac surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age equals or over 65
    1. Scheduled for spinal or joint replacement surgery under generalanesthesia,estimated surgery time over 2h.
    1. Signed written informed consent obtained
    1. Non-surgical Controls are age and sex - matched community elderly residents.

Exclusion

Exclusion Criteria:

    1. Disease of the central nervous system that impairs cognitive function, includingall kinds of dementia, and depression
    1. MMSE score < 24
    1. Received education for less than 5 years
    1. Currently taking sedative or antidepressant drugs
    1. Has taken vitamin B12, folic acid or their derivatives (methycobalamin, cobalamin,tetrahydrofolic acid, etc.) within 6 months.
    1. Has accepted cardiac or neurological surgery within one year.
    1. Was admitted for other clinical trials within 3 month
    1. Patients that regularly taking drugs that affect vitamin B absorption, includingcolchicine, neomycin, salicylate.
    1. Has severe visual or auditory problems
    1. Alcohol or drug dependent (alcohol dependent: drank more than 100 mL of Chineseliqueur with alcohol concentration over 40% everyday for the past 3 months).
    1. Patients that are already admitted for this study can not be admitted the secondtime, no matter the cause of surgery

Study Design

Total Participants: 40
Study Start date:
January 10, 2019
Estimated Completion Date:
July 29, 2021

Study Description

Vitamin B12 has long been suggested to have neural nutrient effect and widely used in clinical settings for patients with peripheral nerve injury as well as complementary medicine for patients with CNS disorders, including cognitive dysfunction. Evidences showed that, although no significant improvement in cognitive function was observed in healthy elderly after vitamin B12 supplementation, some studies suggested that patients with pre-existing CNS disorder may benefit from Vitamin B12. Post operational cognitive dysfunction (POCD) is severe, and long-lasting complication that affects as high as 53% of patients in high risk surgeries. Age is an independent risk factor for POCD. Researches have shown that serum vitamin B12 level decrease with age, and methylcobalamin (active form of Vitamin B12) content in the frontal cortex of aged patients are lower than that of younger patients. However, there are no report on effect of preemptive supplementation of vitamin B12 on POCD incidence. Therefore, the current research is aimed to explore the preoperative methylcobalamin supplementation (500 mg, 3/day for 7 days before surgery) on incidence of POCD. Folic acid supplementation is a common companion for vitamin B12 treatment in clinical settings because they are in the same methionine cycle, increase of one may result in deficiency of another. So we added 5 mg, 1/day of folic acid with methylcobalamin in the treatment group.

This study will recruit patients more than 65 years old eligible for non-cardiac surgery. Patients who participate will take either vitamin B12 and folic acid supplementation or placebo for 7 days before surgery. Neuropsychological test battery (NPB) will be tested before intervention and at discharge for determination of Post operative cognitive dysfunction (POCD). Another group of non-surgical elderly participants will also be tested for NPB to account for learning effect in POCD diagnosis. The hypothesis is that preoperative vitamin B12 supplementation will reduce the incidence of POCD in elderly patients undergoing non-cardiac surgery.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • Shenzhen University General Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Tangdu Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Shanghai 10th People's Hospital

    Shanghai, 200072
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Forth People's Hospital

    Shanghai,
    China

    Site Not Available

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