An interventional study of Folic acid and vitamin B12 and brown sugar aqueous in Delirium, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Prevention
Comparison of preoperative folic acid and VitB12 intervention on postoperative delirium and long-term neurobehavioral changes in children under general anesthesia
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 360 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 160 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
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
Dietary Supplement: Folic acid and vitamin B12
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
Dietary Supplement: brown sugar aqueous
Take folic acid and VitB12 for 3 consecutive days before surgery
take 20 ml of brown sugar aqueous solution with the same concentration as the intervention group 3 days before the operation
PAED scale
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.
Time frame: 10 minutes after surgery
Gesell scale
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.
Time frame: 2 day after surgery
Heart Rate
Observe heart rate through a monitor
Time frame: 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);
Mean Blood Pressure
Observe and calculated mean blood pressure through a monitor
Time frame: 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);
Extubation time
Extubation time
Time frame: immediately after surgery
Ramsay sedation score
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.
Time frame: 10 minutes after extubation
Postoperative pain CHEOPs scores
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
Time frame: 20 minutes after extubation
Narcotic drugs
The use of narcotic drugs (eg pentazocine, propofol)
Time frame: During the surgery
Other adverse events during the recovery period
Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
Time frame: Immediately after the surgery
recovery time
recovery time
Time frame: immediately after recovery
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University