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Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

A

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Anesthesia

Treatments

Procedure: general anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT03002792
2014KTCL03_05

Details and patient eligibility

About

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

Full 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.

Enrollment

360 estimated patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

360 participants in 2 patient groups

general anesthesia
Description:
caries treatment under general anesthesia
Treatment:
Procedure: general anesthesia
caries treatment only
Description:
caries treatment without general anesthesia

Trial contacts and locations

1

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Central trial contact

Hui Zhang, M.D.

Data sourced from clinicaltrials.gov

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