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

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Folic acid and vitamin B12
brown sugar aqueous
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA grade is Ⅰ ~ Ⅱ;
  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

Sites / Locations

  • ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Heart Rate
Observe heart rate through a monitor
Mean Blood Pressure
Observe and calculated mean blood pressure through a monitor
Extubation time
Extubation time
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.
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
Narcotic drugs
The use of narcotic drugs (eg pentazocine, propofol)
Other adverse events during the recovery period
Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
recovery time
recovery time

Full Information

First Posted
June 14, 2020
Last Updated
June 29, 2020
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT04456985
Brief Title
Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
Official Title
Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic acid and vitamin B12
Intervention Description
Take folic acid and VitB12 for 3 consecutive days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
brown sugar aqueous
Intervention Description
take 20 ml of brown sugar aqueous solution with the same concentration as the intervention group 3 days before the operation
Primary Outcome Measure Information:
Title
PAED scale
Description
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
Title
Gesell scale
Description
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
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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);
Title
Mean Blood Pressure
Description
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);
Title
Extubation time
Description
Extubation time
Time Frame
immediately after surgery
Title
Ramsay sedation score
Description
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
Title
Postoperative pain CHEOPs scores
Description
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
Title
Narcotic drugs
Description
The use of narcotic drugs (eg pentazocine, propofol)
Time Frame
During the surgery
Title
Other adverse events during the recovery period
Description
Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
Time Frame
Immediately after the surgery
Title
recovery time
Description
recovery time
Time Frame
immediately after recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lei zhang, Doctor
Phone
0086-18717822662
Email
weiymzhl@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
hong jiang, Doctor
Phone
0086-021-23271699
Email
jianghongjiuyuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hong jiang, Doctor
Organizational Affiliation
Director of Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lei zhang, doctor
Phone
+86-18717822662
Email
weiymzhl@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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