Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

• Conditions: Anesthesia
• Interventions: Procedure: general anesthesia

• Registration Number: NCT03002792
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Status Verified: 2017-01
• Study Start: 2017-01
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28
• Primary Completion: 2018-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
general anesthesia	general anesthesia	caries treatment under general anesthesia

Primary Outcome Measures

Name	Time	Method
Full Scale Intelligence Quotient (IQ)	24-28 weeks after enrollment	according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Stomatology, the Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China