Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study

NCT03359044 | Unknown

• 1 other identifier: SAHoWMU-CR2017-03-208
• Study Type: observational
• Target: 290
• Locations: 0 countries
• Sites: N/A

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

Keywords

Fiberoptic bronchoscopy; Neuropsychological Development; general anesthesia

Outcome Measures

Primary Outcomes (1)

• The detection rate of abnormal behavior in both groups

  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.

  Three years after operation

Secondary Outcomes (1)

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

  Three years after operation

Study Arms (2)

Sedation + topical anesthesia

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

General anesthesia+ topical anesthesia

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

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

(1)Age 4-10Years;(2)ASAⅠ～Ⅱ;(3)Plan to accept fiberoptic bronchoscopy treatment;(4) lives in the city where the research unit is located;(5)signed informed consent

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Pneumonia; Pulmonary Atelectasis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: February 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 4, 2018

Record last verified: 2017-10