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

Shanghai Jiao Tong University

Status: Completed

Conditions: Long Term Neurobehavioral Effects

Study type: Observational

Funder types: Other

Identifiers

NCT04291274

SH9H-2019-T293-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

inhalation anesthesia group

Description:

Unilateral and Bilateral cochlear implantation,which used inhalation anesthesia

intravenous anesthesia group

Description:

Unilateral and Bilateral cochlear implantation, which used intravenous anesthesia