Study of the Effect of General Anesthesia on Children's Behavior

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05164913
Collaborator
(none)
1,140
1
40
28.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Achenbach Child Behavior Checklist (CBCL)scale

Study Design

Study Type:
Observational
Anticipated Enrollment :
1140 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Study of the Effect of General Anesthesia on Children's Behavior
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Control group

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

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

Single anesthesia group

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Achenbach Child Behavior Checklist (CBCL)scale [immediately after the procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Ninth People's Hospital Shanghai Shanghai China 200000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT05164913
Other Study ID Numbers:
  • SH9H-2019-T12
First Posted:
Dec 21, 2021
Last Update Posted:
Dec 21, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 21, 2021