Folic Acid Intervention During Recovery

October 23, 2019 updated by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Effect of Preoperative Folic Acid Intervention on Postoperative Recovery Period in Children With Head and Neck and Maxillofacial Surgery

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to literature review, the incidence of sputum sputum in children is about 38.8% (Reference 1), and the incidence of sputum sputum in the placebo group is 38%, assuming a class of error probability α = 0.05, test efficiency 1-β=0.8, considering folic acid supplementation for 7 days can reduce the incidence of sputum to 23%. A chi-square test is proposed to assess whether there is a difference in the incidence of sputum between groups. Calculated by PASS software, the sample size was 300. Considering the 5% drop rate, a total of 316 inpatients with head and neck and maxillofacial surgery were included, divided into 2 groups, 158 cases in each group.

The PAED score was scored every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation (total score 0-20, score ≥10 is defined as the recovery period).

8.2 secondary observation indicators:

  1. Changes in induction of anesthesia, intubation, and central rate (HR) and mean blood pressure (MBP);
  2. HR and MBP changes in the resuscitation chamber (T1), 5 min (T2) before extubation, T3 at extubation, and 2 min (T4) after extubation;
  3. extubation time and wake-up time;
  4. Postoperative Ramsay sedation scores were performed every 10 minutes during recovery, at the time of extubation, and within 30 minutes after extubation;
  5. Postoperative pain CHEOPs scores were taken every 10 minutes during extubation and 30 min after extubation (the total score was less than 6 points and no pain was observed, and ≥10 points were treated with corresponding analgesia);
  6. The use of anesthetic drugs (eg, pentazocine, propofol);
  7. Changes of serum IL-6, TNF-α and folic acid concentrations before and after surgery.
  8. Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention group
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
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).
EXPERIMENTAL: Placebo group
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of sputum in children
Time Frame: 8 days
The incidence of sputum in children with major indicators was tested by chi-square test or exact probability method.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ren zhou, Doctor, Shanghai Ninth People Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SH9H-2019-T122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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