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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456985
• Other study ID #: SH9H-2020-T57-2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2020
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: lei zhang, Doctor
• Phone: 0086-18717822662
• Email: weiymzhl[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

1. ASA grade is ? ~ ?;

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

Related Conditions & MeSH terms

• Delirium

Intervention

Dietary Supplement:
• Folic acid and vitamin B12
Take folic acid and VitB12 for 3 consecutive days before surgery
• brown sugar aqueous
take 20 ml of brown sugar aqueous solution with the same concentration as the intervention group 3 days before the operation

Locations

Country	Name	City	State
China	China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes after surgery
Primary	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.	2 day after surgery
Secondary	Heart Rate	Observe heart rate through a monitor	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);
Secondary	Mean Blood Pressure	Observe and calculated mean blood pressure through a monitor	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);
Secondary	Extubation time	Extubation time	immediately after surgery
Secondary	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.	10 minutes after extubation
Secondary	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	20 minutes after extubation
Secondary	Narcotic drugs	The use of narcotic drugs (eg pentazocine, propofol)	During the surgery
Secondary	Other adverse events during the recovery period	Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)	Immediately after the surgery
Secondary	recovery time	recovery time	immediately after recovery