BehaviorNCT05164913
Study of the Effect of General Anesthesia on Children's Behavior
An observational study of Behavior, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Behavior
- What is being tested?
- Achenbach Child Behavior Checklist （CBCL）scale
- How many people
- 1,140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Jan 2023
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- Child, Adult
Study population: Children without basic behavioral abnormalities who have undergone surgery in this hospital
Who may be able to join
- Children aged 0-5 who underwent surgery at Shanghai Ninth People's Hospital
- Current age is less than 18 years old
- No surgical complications such as acute infectious diseases, systemic diseases
Who cannot join
- History of neonatal hypoxic ischemic encephalopathy and bilirubin encephalopathy
- There are genetic diseases or chromosomal diseases, neurological diseases (including epilepsy, congenital diseases), or a history of head trauma, a history of central nervous system infectious diseases, high fever convulsions, congenital heart disease, tumor diseases, and Patients with blood diseases
- People who have autism, attention deficit hyperactivity disorder, or have received behavioral related treatments and interventions
- Those who have undergone cardiovascular surgery, neurosurgery, or those with unstable hemodynamics during surgery
- Those who cannot be contacted, refused to join the group, the questionnaire information does not match the medical records, or the complete medical records cannot be obtained
Trial locations and contacts
1 site in 1 country.
Hong Jiang contact
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200000
Ren Zhou, +8615121007303, 318281114@qq.com
About this study
Official title: A Retrospective Study of the Effect of General Anesthesia on Children's Behavior
This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Children living in a specific family environment may be more susceptible to the effects of anesthetic drugs. People who are susceptible to exposure to narcotic drugs. In order to clarify this hypothesis and discover specific family environment factors that interact with anesthetic drug exposure, this project intends to establish a retrospective cohort study, through hierarchical analysis and other means, to clarify the behavioral changes of children in different family environments after exposure to anesthetic drugs. Provide theoretical support for the safe application of clinical children's anesthetics.
- Conditions
- Behavior
- Being tested
- Achenbach Child Behavior Checklist （CBCL）scale
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achenbach Child Behavior Checklist （CBCL）scaleOther
Use the Achenbach Child Behavior Checklist （CBCL）scale to assess children's behavior
| Study group | Role | What they receive |
|---|---|---|
| Control group | No general anesthesia between 0-3 years old or 0-5 years old Receives: Other: Achenbach Child Behavior Checklist （CBCL）scale | |
| Single anesthesia group | Only once general anesthesia between 0-3 years old or 0-5 years old Receives: Other: Achenbach Child Behavior Checklist （CBCL）scale | |
| Multiple anesthesia group | More than once general anesthesia between 0-3 years old or 0-5 years old Receives: Other: Achenbach Child Behavior Checklist （CBCL）scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achenbach Child Behavior Checklist （CBCL）scale
sorce（0-100），higher scores mean a worse
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Sep 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164913
- Sponsor's protocol ID
- SH9H-2019-T12
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Effect of General Anesthesia on Children's Behavior
- ClinicalTrials.gov ID
- NCT05164913
- Acronym / sponsor ID
- SH9H-2019-T12
- Conditions
- Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Dec 2021 (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.
This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Children living in a specific family environment may be more susceptible to the effects of anesthetic drugs. People who are susceptible to exposure to narcotic drugs. In order to clarify this hypothesis and discover specific family environment factors that interact with anesthetic drug exposure, this project intends to establish a retrospective cohort study, through hierarchical analysis and other means, to clarify the behavioral changes of children in different family environments after exposure to anesthetic drugs. Provide theoretical support for the safe application of clinical children's anesthetics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Achenbach Child Behavior Checklist （CBCL）scaleNo general anesthesia between 0-3 years old or 0-5 years old |
| Single anesthesia group | – | Other: Achenbach Child Behavior Checklist （CBCL）scaleOnly once general anesthesia between 0-3 years old or 0-5 years old |
| Multiple anesthesia group | – | Other: Achenbach Child Behavior Checklist （CBCL）scaleMore than once general anesthesia between 0-3 years old or 0-5 years old |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children without basic behavioral abnormalities who have undergone surgery in this hospital
Key inclusion criteria (3 listed)
- Children aged 0-5 who underwent surgery at Shanghai Ninth People's Hospital
- Current age is less than 18 years old
- No surgical complications such as acute infectious diseases, systemic diseases
Key exclusion criteria (5 listed)
- History of neonatal hypoxic ischemic encephalopathy and bilirubin encephalopathy
- There are genetic diseases or chromosomal diseases, neurological diseases (including epilepsy, congenital diseases), or a history of head trauma, a history of central nervous system infectious diseases, high fever convulsions, congenital heart disease, tumor diseases, and Patients with blood diseases
- People who have autism, attention deficit hyperactivity disorder, or have received behavioral related treatments and interventions
- Those who have undergone cardiovascular surgery, neurosurgery, or those with unstable hemodynamics during surgery
- Those who cannot be contacted, refused to join the group, the questionnaire information does not match the medical records, or the complete medical records cannot be obtained
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 |
|---|---|---|
| Achenbach Child Behavior Checklist （CBCL）scaleUse the Achenbach Child Behavior Checklist （CBCL）scale to assess children's behavior | Other | Control group, Multiple anesthesia group, Single anesthesia group |
Primary outcome
Achenbach Child Behavior Checklist （CBCL）scale
Time frame: immediately after the procedure
sorce（0-100），higher scores mean a worse
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Hong Jiang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 3 inclusion and 5 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ren Zhou (+8615121007303, 318281114@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achenbach Child Behavior Checklist （CBCL）scale (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.