The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）

Study Overview
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Brief Summary
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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 children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after intravenous or inhalation anesthesia by a ambispective cohort study.

Detailed Description
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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. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ ≤54 is moderate neurological damage, 25 B DQ B 39 is severe neurological damage, and DQ< 25 is very severe neurological damage.

Official Title
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Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment

Conditions
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Long Term Neurobehavioral Effects

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| inhalation anesthesia group<br>Unilateral and Bilateral cochlear implantation,which used inhalation anesthesia | |
| intravenous anesthesia group<br>Unilateral and Bilateral cochlear implantation, which used intravenous anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Baseline Gesell Developmental Scale after 6 month | Neurobehavior effects was measured use Gesell Developmental Scale. DQ (Developmental quotient) was calculated by (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ≤54 is moderate neurological damage, 25≤DQ≤39 is severe neurological damage, and DQ <25 is very severe neurological damage | change in 6 months after surgery] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, anesthesia, neurobehavioral development