Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

Comparison of preoperative folic acid and VitB12 intervention on postoperative delirium and long-term neurobehavioral changes in children under general anesthesia.

It had two arms (groups): Intervention group (active comparator) and Placebo group (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Folic acid, as a one-carbon unit transferase coenzyme, participates in the synthesis of purine and thymine, and is an important element of the nervous system.

Vitamin B12 participates in methyl conversion and folate metabolism in the body, promoting the conversion of 5-methyltetrahydrofolate to tetrahydrofolate.

The explanation mechanism of the relationship between folic acid deficiency and cognitive dysfunction may be that folic acid deficiency leads to impaired central nervous system methylation, resulting in insufficient methyl synthesis of myelin sheaths, neurotransmitters, membrane phospholipids and deoxyribonucleic acid.

Therefore, this study further explored the preoperative folic acid and coenzyme B12 supplementation for children's delirium and long-term neurobehavioral changes after general anesthesia.

Who Took Part

The registry lists 360 planned participants were the target.

It was open to people of any sex aged from 6 months up to 24 months.

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

Examples of who could join: ASA grade is Ⅰ \~ Ⅱ;. Children aged 6 months to 2 years old;. It is planned to undergo head, neck and maxillofacial surgery under general anesthesia with anesthesia for less than 6 hours.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: children with a history of respiratory tract infection within 1 week;; children with congenital malformations such as congenital heart disease;; children with central nervous system diseases or mental disorders or mental disorders;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-06-01 with completion listed for 2025-06-30.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: PAED scale (time frame: 10 minutes after surgery). Gesell scale (time frame: 2 day after surgery).

It also tracked 8 secondary outcomes, for example Heart Rate, Mean Blood Pressure, Extubation time, Ramsay sedation score, Postoperative pain CHEOPs scores and Narcotic drugs.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 360 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.