Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.

Detailed Description
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Participants, according to the state of illness and clinical requirements, assigned to receive dental caries treatment with or without general anesthesia. During the follow-up, various of neurodevelopment assessment will be done at specific timepoint to investigate whether general anaesthesia will influence neurodevelopment.

Official Title
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Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age>=36 weeks American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited systemic disease. Age<=6 yr Exclusion Criteria: did not provide research authorization； unable to contact or inconvenient for follow-up; hypersensitive to general anesthesia drug; previous exposure to general anesthesia in utero; previous exposure to general anesthesia as a neonate previous exposure to psychotropic medication; complications at birth such as low weigh, hypoxia, or cerebral edema; any other known diseases may influence the neurodevelopment

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| general anesthesia<br>caries treatment under general anesthesia | Procedure: general anesthesia<br>* nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane<br>|
| caries treatment only<br>caries treatment without general anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Scale Intelligence Quotient (IQ) | according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV) | 24-28 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Comprehension Index | according to WPPSI-IV | 24-28 weeks after enrollment | 
| Visual Spatial Index | according to WPPSI-IV | 24-28 weeks after enrollment | 
| Fluid Spatial Index | according to WPPSI-IV | 24-28 weeks after enrollment | 
| Working Memory Index | according to WPPSI-IV | 24-28 weeks after enrollment | 
| Processing Speed Index | according to WPPSI-IV | 24-28 weeks after enrollment | 
| Executive Function | according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) | 24-28 weeks after enrollment | 
| Adaptive Behavior | according to Adaptive Behavior Assessment System second edition | 24-28 weeks after enrollment | 
| Emotion Comprehension | according to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000) | 24-28 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, neurodevelopment, dental caries