Folic Acid Intervention During Recovery

NCT04135885 | Unknown

• 1 other identifier: SH9H-2019-T122
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research purposes：Comparison of preoperative folic acid and placebo intervention on postoperative recovery of sputum in children undergoing general anesthesia for head and neck and maxillofacial surgery Test type：Randomized, double-blind, placebo-controlled, prospective study Randomized grouping: Patients were randomized into an intervention group (fed for 7 days before surgery) and a placebo group (7 days for placebo) Test subjects: recruitment and sample size calculation, inclusion criteria, exclusion criteria, shedding cases, trial suspension, rejection criteria, trial termination,Test contents Evaluation indicators: main observation indicators, secondary observation indicators Adverse events: definition of adverse events, recording of adverse events, treatment of adverse events, assessment of adverse events, serious adverse events, definition of serious adverse events, recording and reporting of serious adverse events

Conditions

Adverse Effect of Other General Anesthetics

Keywords

Folic Acid; Placebo

Outcome Measures

Primary Outcomes (1)

• The incidence of sputum in children

  The incidence of sputum in children with major indicators was tested by chi-square test or exact probability method.

  8 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: patients took 7 days of folic acid tablets before surgery (0.3mg/d for children aged 1-3, 0.4mg/d for children aged 4\~5 years, dissolved in 20ml brown sugar water.)

Drug: Folic Acid

Placebo group

EXPERIMENTAL

Placebo group: The patient received the same dose of brown sugar water for 7 days before surgery. Folic acid dose selection is based on the maximum daily intake of children（tolerable upper intake levels，UL）

Drug: Folic Acid; Drug: Placebos

Interventions

Folic Acid DRUG

The patient was continuously taking 7 ml of a brown sugar aqueous solution containing a certain amount of folic acid for 7 days before surgery (0.3 mg/d for children with 1-3 years old and 0.4 mg/d for children aged 4 to 5, once a day). After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0\~20 points, and the score ≥10 points is defined as the recovery period).

Intervention group; Placebo group

Placebos DRUG

Patients in the placebo group received 20 ml of an aqueous solution of brown sugar with the same concentration as the intervention group on the 7th day before surgery. After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0\~20 points, and the score ≥10 points is defined as the recovery period).

Placebo group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA is graded from I to II
• Children between the ages of 1 and 5
• The weight is greater than or equal to 8.5kg
• It is planned to undergo head and neck and maxillofacial surgery under general anesthesia

You may not qualify if:

• Children with a history of respiratory infection within 1 week
• Children with congenital malformations such as congenital heart disease
• Children with central nervous system diseases or those with mental disorders or mental disorders
• Children with long-term use of sedative or analgesic drugs
• Children with severe liver and kidney dysfunction
• receiving folic acid supplementation therapy or taking related derivatives
• Taking drugs that affect absorption in the past 1 month, such as sulfonamides, aspirin, etc.
• Participated in other related clinical studies in the past 3 months

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Related Publications (1)

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ren zhou, Doctor

  shanghai Ninth People Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lei zhang, Doctor

CONTACT

18717822662; weiymzhl@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: December 30, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share