Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study

S

Second Affiliated Hospital of Wenzhou Medical University

Status

Unknown

Conditions

Cough
Atelectasis
Pneumonia

Study type

Observational

Funder types

Other

Identifiers

NCT03359044
SAHoWMU-CR2017-03-208

Details and patient eligibility

About

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.

Enrollment

290 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

290 participants in 2 patient groups

Sedation + topical anesthesia
Description:
midazolam 0.1~0.2 mg/kg for sedation, 2%lidocaine for topical anesthesia
General anesthesia+ topical anesthesia
Description:
propofol 4~5mg/kg、Remifentanil2~3μg/kg for induction ,insert Laryngeal Mask Airway(LMA) , 2%lidocaine for topical anesthesia

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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