Overview
Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients
Status:
Terminated
Terminated
Trial end date:
2021-07-29
2021-07-29
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Xijing HospitalCollaborators:
Anhui Provincial Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Shanghai 10th People's Hospital
Tang-Du Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolTreatments:
Folic Acid
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Criteria
Inclusion Criteria:- 1. Age equals or over 65
- 2. Scheduled for spinal or joint replacement surgery under general
anesthesiaļ¼estimated surgery time over 2h.
- 3. Signed written informed consent obtained
- 4. Non-surgical Controls are age and sex - matched community elderly residents.
Exclusion Criteria:
- 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