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

Completed

• Conditions: Long Term Neurobehavioral Effects

• Registration Number: NCT04291274
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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 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

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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of Baseline Gesell Developmental Scale after 6 month	change in 6 months after surgery]	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

Trial Locations

Locations (2)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, China

Shanghai No.9 People's Hospital; 🇨🇳 Shanghai, China