NCT05164913

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,140

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 21, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

October 22, 2021

Last Update Submit

December 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Achenbach Child Behavior Checklist (CBCL)scale

    sorce(0-100),higher scores mean a worse

    immediately after the procedure

Study Arms (3)

Control group

No general anesthesia between 0-3 years old or 0-5 years old

Other: Achenbach Child Behavior Checklist (CBCL)scale

Single anesthesia group

Only once general anesthesia between 0-3 years old or 0-5 years old

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

Other: Achenbach Child Behavior Checklist (CBCL)scale

Interventions

Use the Achenbach Child Behavior Checklist (CBCL)scale to assess children's behavior

Control groupMultiple anesthesia groupSingle anesthesia group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children without basic behavioral abnormalities who have undergone surgery in this hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Behavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

December 21, 2021

Study Start

September 1, 2019

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

December 21, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations