Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
Delirium
About this trial
This is an interventional prevention trial for Delirium
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention group
Placebo group
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
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