Adverse Effect of Other General AnestheticsNCT04135885
Folic Acid Intervention During Recovery
A study testing Folic Acid in people with Adverse Effect of Other General Anesthetics, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Adverse Effect of Other General Anesthetics
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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:
- Changes in induction of anesthesia, intubation, and central rate (HR) and mean blood pressure (MBP);
- HR and MBP changes in the resuscitation chamber (T1), 5 min (T2) before extubation, T3 at extubation, and 2 min (T4) after extubation;
- extubation time and wake-up time;
- Postoperative Ramsay sedation scores were performed every 10 minutes during recovery, at the time of extubation, and within 30 minutes after extubation;
- 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);
- The use of anesthetic drugs (eg, pentazocine, propofol);
- Changes of serum IL-6, TNF-α and folic acid concentrations before and after surgery.
- Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
- Being tested
- Folic Acid, Placebos
- Keywords
- Folic Acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
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).
PlacebosDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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） Receives: Drug: Folic Acid; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start30 Dec 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Effect of Other General AnestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ren zhou, Doctor, Principal investigator, shanghai Ninth People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135885
- Sponsor's protocol ID
- SH9H-2019-T122
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15114210
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Folic Acid Intervention on Postoperative Recovery Period in Children With Head and Neck and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT04135885
- Acronym / sponsor ID
- SH9H-2019-T122
- Keywords
- Folic Acid, Placebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Changes in induction of anesthesia, intubation, and central rate (HR) and mean blood pressure (MBP);
- HR and MBP changes in the resuscitation chamber (T1), 5 min (T2) before extubation, T3 at extubation, and 2 min (T4) after extubation;
- extubation time and wake-up time;
- Postoperative Ramsay sedation scores were performed every 10 minutes during recovery, at the time of extubation, and within 30 minutes after extubation;
- 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);
- The use of anesthetic drugs (eg, pentazocine, propofol);
- Changes of serum IL-6, TNF-α and folic acid concentrations before and after surgery.
- Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Folic AcidIntervention 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.) |
| Placebo group | Experimental | Drug: Folic Acid, Drug: PlacebosPlacebo 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） |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidThe 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 | Intervention group, Placebo group |
| PlacebosPatients 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). | Drug | Placebo group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Background: PubMed 15114210Sikich 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ren zhou, Doctor principal investigator
shanghai Ninth People Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid in people with Adverse Effect of Other General Anesthetics, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lei zhang, Doctor (18717822662, weiymzhl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of sputum in children (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.