Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
1 other identifier
interventional
360
1 country
1
Brief Summary
Comparison of preoperative folic acid and VitB12 intervention on postoperative delirium and long-term neurobehavioral changes in children under general anesthesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 7, 2020
June 1, 2020
5.1 years
June 14, 2020
June 29, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (8)
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);
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);
Extubation time
immediately after surgery
Ramsay sedation score
10 minutes after extubation
Postoperative pain CHEOPs scores
20 minutes after extubation
- +3 more secondary outcomes
Study Arms (2)
Intervention group
ACTIVE COMPARATORBefore 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
Placebo group
PLACEBO COMPARATORThe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China
Shanghai, Shanghai Municipality, 200001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
hong jiang, Doctor
Director of Anesthesiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief Physician and Associate Researcher
Study Record Dates
First Submitted
June 14, 2020
First Posted
July 7, 2020
Study Start
June 1, 2020
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
July 7, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share