Status:
TERMINATED
Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
First Affiliated Hospital Xi'an Jiaotong University
Tang-Du Hospital
Conditions:
Post Operative Cognitive Dysfunction
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 bef...
Detailed 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 CN...
Eligibility Criteria
Inclusion
- 1\. Age equals or over 65
- 2\. Scheduled for spinal or joint replacement surgery under general anesthesia，estimated surgery time over 2h.
- 3\. Signed written informed consent obtained
- 4\. Non-surgical Controls are age and sex - matched community elderly residents.
Exclusion
- 1\. Disease of the central nervous system that impairs cognitive function, including all kinds of dementia, and depression
- 2\. MMSE score \< 24
- 3\. Received education for less than 5 years
- 4\. Currently taking sedative or antidepressant drugs
- 5\. Has taken vitamin B12, folic acid or their derivatives (methycobalamin, cobalamin, tetrahydrofolic acid, etc.) within 6 months.
- 6\. Has accepted cardiac or neurological surgery within one year.
- 7\. Was admitted for other clinical trials within 3 month
- 8\. Patients that regularly taking drugs that affect vitamin B absorption, including colchicine, neomycin, salicylate.
- 9\. Has severe visual or auditory problems
- 10\. Alcohol or drug dependent (alcohol dependent: drank more than 100 mL of Chinese liqueur with alcohol concentration over 40% everyday for the past 3 months).
- 11\. Patients that are already admitted for this study can not be admitted the second time, no matter the cause of surgery
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03485404
Start Date
January 10 2019
End Date
July 29 2021
Last Update
August 4 2021
Active Locations (13)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Shenzhen University General Hospital
Shenzhen, Guangdong, China
3
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
4
Henan Provincial People's Hospital
Zhengzhou, Henan, China