Folic Acid Intervention During Recovery

• Status: Not yet recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

1. ASA is graded from I to II

2. Children between the ages of 1 and 5

3. The weight is greater than or equal to 8.5kg

4. It is planned to undergo head and neck and maxillofacial surgery under general anesthesia

Exclusion Criteria:

1. Children with a history of respiratory infection within 1 week

2. Children with congenital malformations such as congenital heart disease

3. Children with central nervous system diseases or those with 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. receiving folic acid supplementation therapy or taking related derivatives

7. Taking drugs that affect absorption in the past 1 month, such as sulfonamides, aspirin, etc.

8. Participated in other related clinical studies in the past 3 months