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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Delirium

Treatments: Dietary Supplement: Folic acid and vitamin B12; Dietary Supplement: brown sugar aqueous

Study type: Interventional

Funder types: Other

Identifiers

NCT04456985

SH9H-2020-T57-2

Details and patient eligibility

About

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

Full description

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. It has been reported that the lack of serum folic acid and B12 is associated with an increased risk of cognitive impairment. 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. Our previous studies showed that preoperative folic acid supplementation can alleviate myelin damage and cognitive impairment in young rats caused by sevoflurane anesthesia. 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ASA grade is Ⅰ ~ Ⅱ;
2. Children aged 6 months to 2 years old;
3. It is planned to undergo head, neck and maxillofacial surgery under general anesthesia with anesthesia for less than 6 hours

Exclusion criteria

1. Children with a history of respiratory tract infection within 1 week;
2. Children with congenital malformations such as congenital heart disease;
3. Children with central nervous system diseases or mental disorders or mental disorders;
4. Children with long-term use of sedative or analgesic drugs;
5. Children with severe liver and kidney dysfunction;
6. Received folic acid and VitB12 supplement treatment or taken related derivatives;
7. Have taken drugs that affect absorption within the past month, such as sulfonamides, aspirin, etc .;
8. Those who have participated in other relevant clinical research in the past 3 months;
9. Children with stunting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Before the operation, the patient took 20ml of brown sugar aqueous solution containing folic acid and VitB12 for 3 days (folic acid concentration is 0.4mg / d for 2 year old children + 1.2μg / d of VitB12, dissolved in 20ml brown sugar water once a day). Postoperatively, PAED scores were performed at the time of awakening, extubation and every 10min within 30min after extubation. 10 points is defined as delirium during the recovery period). Long-term neurobehavioral changes were evaluated using the Gesell scale, followed up every six months until the age of three

Treatment:

Dietary Supplement: Folic acid and vitamin B12

Placebo group

Placebo Comparator group

Description:

The patients in the placebo group took 20 ml of brown sugar aqueous solution with the same concentration as the intervention group 3 days before the operation. Postoperatively, PAED scores were performed at the time of recovery, extubation, and every 10 minutes within 30 minutes after extubation. The PAED scores of all children were measured by the same person. (The total score is 0-20, and the score ≥10 is defined as delirium during the recovery period). Long-term neurobehavioral changes were evaluated using the Gesell scale, followed up every six months until the age of three

Treatment:

Dietary Supplement: brown sugar aqueous