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

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.

Study Overview

• Status: Recruiting
• Conditions: Behavior
• Intervention / Treatment: Other: Achenbach Child Behavior Checklist （CBCL）scale

• Study Type: Observational
• Enrollment (Anticipated): 1140

Contacts and Locations

• Study Contact: Name: Ren Zhou; Phone Number: +8615121007303; Email: 318281114@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Ninth People's Hospital
      • Contact: Ren Zhou; Phone Number: +8615121007303; Email: 318281114@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achenbach Child Behavior Checklist （CBCL）scale	sorce（0-100），higher scores mean a worse	immediately after the procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SH9H-2019-T12

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