Status:
COMPLETED
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Long Term Neurobehavioral Effects
Eligibility:
All Genders
6-36 years
Brief Summary
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that...
Detailed Description
Gesell development scale contains five subscales including adaptability, fine motor, gross motor, language, and social skill evaluation. Developmental quotient (DQ) = (development age/actual age)×100....
Eligibility Criteria
Inclusion
- Children undergoing cochlear implantation under general anesthesia
- 6 to 36-month-old child
- Normal body weight
- Children with normal structures of the inner ear and auditory nerve
- Children without contraindications to anesthesia and surgery
- Patients who have not participated in other clinical trials
- Without any acute infectious diseases or systematic diseases
Exclusion
- The participants with a Gesell score (fine motor and gross motor) lower than 86 after preoperative evaluation.
- With other illness which could affects curative effect of recovery, such as inner ear malformations (except for large vestibular aqueduct syndrome), auditory vestibular nerve dysplasia, dysgnosia and mental disease;
- Inability to cooperate with the hearing evaluation and the language training
- Cute and chronic otitis media and mastoiditis, unhealed tympanic membrane perforation
- Abnormal structure of brain, including white matter dysplasia, Demyelinating Diseases
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04291274
Start Date
November 1 2019
End Date
December 30 2019
Last Update
September 20 2021
Active Locations (2)
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1
Shanghai ninth people's hospital
Shanghai, China
2
Shanghai No.9 People's Hospital
Shanghai, China