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

• Status: Terminated
• Trial end date: 2021-07-29
• Target enrollment: 0
• Participant gender: 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/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Collaborators: 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 School
• Treatments: 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 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 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