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

Not Applicable

Recruiting

• Conditions: Delirium

• Registration Number: NCT04456985
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PAED scale	10 minutes after surgery	Observe whether the index will cause delirium during the recovery period.The evaluation range of the PAED scale is 0-20 points, If the score exceeds 10 points, Then it is considered delirium.
Gesell scale	2 day after surgery	Through the gesell scale, 5 tests are carried out on children: gross motor ability, fine movement, physical ability, verbal ability, and human ability.The evaluation range of the Gesell scale is 0-100 points. If the score is higher, it means good. If the score is low, it means that the result is not good. If the result is not good, it may be caused by anesthesia, so we conducted this evaluation.

Secondary Outcome Measures

Name	Time	Method
Extubation time	immediately after surgery	Extubation time
Ramsay sedation score	10 minutes after extubation	Ramsay sedation score after recovery, extubation and every 10min within 30min after extubation，Ramsay sedation score is 1-6 points. If the score is 2-4 points，That result is satisfactory, 5-6 points are excessive sedation.
Narcotic drugs	During the surgery	The use of narcotic drugs (eg pentazocine, propofol)
Postoperative pain CHEOPs scores	20 minutes after extubation	The postoperative pain CHEOPs scores were taken at the time of extubation and every 10 minutes within 30 minutes after extubation (the total score was less than 6 points, there was no pain, and ≥10 points for corresponding analgesia treatment).; The total score is 46 points, if the total score is less than 6 points, it is judged as no pain
Other adverse events during the recovery period	Immediately after the surgery	Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
Heart Rate	During the induction period of anesthesia, intubation, and the operation period；immediately after entering the resuscitation room (T1), 5 minutes before extubation (T2), immediately after extubation (T3), and 2 minutes after extubation (T4);	Observe heart rate through a monitor
recovery time	immediately after recovery	recovery time
Mean Blood Pressure	During the induction period of anesthesia, intubation, and the operation period；immediately after entering the resuscitation room (T1), 5 minutes before extubation (T2), immediately after extubation (T3), and 2 minutes after extubation (T4);	Observe and calculated mean blood pressure through a monitor

Trial Locations

Locations (1)

China; 🇨🇳 Shanghai, Shanghai, China