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

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12) for post-surgical inflammation and surgery recovery.

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).

It had three arms (groups): VB12+FA (experimental), Placebo (placebo comparator) and Non-surgical controls (other).

Patients with receive oral tablets of placebo for folic acid 1/d and placebo for methylcobalamin 3/d, which look exactly like the interventional drugs as oral supplementation for 7 days before non-cardiac surgery.

The registry classes the interventions as behavioral, drug, other and procedure.

More on the Plan

Age is an independent risk factor for POCD.

However, there are no report on effect of preemptive supplementation of vitamin B12 on POCD incidence.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The post-surgical inflammation and surgery recovery participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the post-surgical inflammation and surgery recovery participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant and care provider.

It started in 2019-01-10 with completion listed for 2021-07-29.

It ran at 13 sites in China (13).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of POCD at discharge or 7 days after operation (time frame: at discharge or at 7 days after operation if the patient is not discharged by then).

It also tracked 5 secondary outcomes, for example Activity daily living score, Serum level of vitamin B12, folic acid and homocysteine and Serum level of cystatin C and myeloid differentiation protein 2.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 40 people with post-surgical inflammation and surgery recovery.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Post-surgical inflammation and surgery recovery research.