Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study

NCT ID: NCT03359044

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-11-30

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.

Conditions

Pneumonia; Atelectasis; Cough

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sedation + topical anesthesia

midazolam 0.1～0.2 mg/kg for sedation, 2%lidocaine for topical anesthesia

No interventions assigned to this group

General anesthesia+ topical anesthesia

propofol 4～5mg/kg、Remifentanil2～3μg/kg for induction ,insert Laryngeal Mask Airway(LMA) , 2%lidocaine for topical anesthesia

No interventions assigned to this group

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SAHoWMU-CR2017-03-208

Identifier Type: -

Identifier Source: org_study_id