Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Long Term Neurobehavioral Effects
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- change of Baseline Gesell Developmental Scale after 6 month
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jingjie Li
associate chief physician
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
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
Outcomes
Primary Outcomes
change of Baseline Gesell Developmental Scale after 6 month
Time Frame: 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