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Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03002792
Enrollment
360
Registered
2016-12-26
Start date
2017-01-31
Completion date
2020-06-30
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

anesthesia, neurodevelopment, dental caries

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREgeneral anesthesia

nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Full Scale Intelligence Quotient (IQ)24-28 weeks after enrollmentaccording to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)

Secondary

MeasureTime frameDescription
Working Memory Index24-28 weeks after enrollmentaccording to WPPSI-IV
Verbal Comprehension Index24-28 weeks after enrollmentaccording to WPPSI-IV
Visual Spatial Index24-28 weeks after enrollmentaccording to WPPSI-IV
Fluid Spatial Index24-28 weeks after enrollmentaccording to WPPSI-IV
Executive Function24-28 weeks after enrollmentaccording to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)
Adaptive Behavior24-28 weeks after enrollmentaccording to Adaptive Behavior Assessment System second edition
Emotion Comprehension24-28 weeks after enrollmentaccording to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000)
Processing Speed Index24-28 weeks after enrollmentaccording to WPPSI-IV

Countries

China

Contacts

Primary ContactHui Zhang, M.D.
zhanghuifmmua@163.com(+86)029-84776119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026