Skip to main content
Clinical Trials/NCT03359044
NCT03359044
Unknown
Not Applicable

Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study

Second Affiliated Hospital of Wenzhou Medical University0 sites290 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Enrollment
290
Primary Endpoint
The detection rate of abnormal behavior in both groups
Last Updated
8 years ago

Overview

Brief Summary

Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods:sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
November 30, 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 4-10 years
  • American society of anesthesiologists(ASA) gradeⅠ~Ⅱ
  • Plan to accept fiberoptic bronchoscopy treatment
  • lives in the city where the research unit is located
  • signed informed consent

Exclusion Criteria

  • preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
  • known congenital malformations may have a potential impact on the development of children's neuropsychological function
  • known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
  • children with contraindications to intravenous general anesthesia

Outcomes

Primary Outcomes

The detection rate of abnormal behavior in both groups

Time Frame: Three years after operation

Using the Achenbach Child Behavior Checklist(CBCL)for Parents.The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.

Secondary Outcomes

  • Full Scale Intelligence Quotient (FSIQ) Score of the Wechsler Intelligence Scale for Children (WISC)-IV(Three years after operation)

Similar Trials