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Folic Acid Intervention During Recovery

NCT04135885 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-10-25

No results posted yet for this study

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

Interventions

DRUG

Folic Acid

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).

DRUG

Placebos

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).

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • ren zhou, Doctor · shanghai Ninth People Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2021-12-30
Completion
2021-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135885 on ClinicalTrials.gov