Long Term Neurobehavioral Effects
Conditions
Keywords
infant, anesthesia, neurobehavioral development
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 unilateral or bilateral cochlear implantation.
Interventions
None listed
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
Inclusion criteria
1. Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital 2. Patients who have not participated in other clinical trials 3. ASA class I-II selective operation without any acute infectious diseases or systematic diseases 4. Infant's family members agree to participated in the trials and sign the informed consent
Exclusion criteria
1. Reject to sign the informed consent and participate in the trials 2. Patients with severe liver and kidney damage or other heart, lung and nervous system diseases 3. The Gesell developmental scale is less than 86 in motor behavior and physical energy 4. With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice 5. Infant who is allergic to egg and milk 6. Family history of malignant hyperthermia 7. Allergy to anesthetic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Baseline Gesell Developmental Scale after 6 month | change in 6 months after surgery | Neurobehavior effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of Baseline Gesell Developmental Scale after 12 month | change in 12 months after surgery | Neurobehavior effects |
Countries
China
Contacts
Primary ContactJingjie Li, M.D
Backup ContactLei Zhang, Ph.D
Outcome results
None listed