Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- PAED scale
研究概览
简要总结
Comparison of preoperative folic acid and VitB12 intervention on postoperative delirium and long-term neurobehavioral changes in children under general anesthesia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
- •Children with long-term use of sedative or analgesic drugs;
- •Children with severe liver and kidney dysfunction;
- •Received folic acid and VitB12 supplement treatment or taken related derivatives;
- •Have taken drugs that affect absorption within the past month, such as sulfonamides, aspirin, etc .;
- •Those who have participated in other relevant clinical research in the past 3 months;
- •Children with stunting
结局指标
主要结局
PAED scale
时间窗: 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
时间窗: 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.
次要结局
- Extubation time(immediately after surgery)
- Ramsay sedation score(10 minutes after extubation)
- Narcotic drugs(During the surgery)
- 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);)
- Postoperative pain CHEOPs scores(20 minutes after extubation)
- Other adverse events during the recovery period(Immediately after the surgery)
- 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);)
- recovery time(immediately after recovery)
研究者
Zhang Lei
Deputy Chief Physician and Associate Researcher
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University