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

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.

Conditions

• Post Operative Cognitive Dysfunction

Interventions

DRUG

methylcobalamin

methylcobalamin tablets, 0.5mg/tablet, 3 tablets/day.

DRUG

Folic Acid

folic acid tablets, 5mg/tablet, 1 tablet/day

OTHER

Placebo for methylcobalamin

orange tablets that looks exactly like methylcobalamin

OTHER

Placebo for folic acid

yellow tablets that looks exactly like folic acid

PROCEDURE

non-cardiac surgery

patients elective for non-cardiac surgery will undergo scheduled surgery after 7 days of intervention

BEHAVIORAL

NPB test

participants will accept Mini-Mental State Examination (MMSE), Patient Health Questionnaire (PHQ-9), ADL, and NPB test before intervention, and NPB by discharge or similar time intermittent after the first assessment for non-surgical controls. Also ADL will be tested again through telephone interview at 3 months after discharge.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Shanghai 10th People's Hospital

  collaborator OTHER

• Xijing Hospital

  lead OTHER

Principal Investigators

• Lize Xiong, M.D., Ph.D. · Xijing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-10

Primary Completion

2021-07-29

Completion

2021-07-29

Countries

• China

Study Locations