Long Term Neurobehavioral Effects Clinical Trial
Official title:
Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
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.
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 6 Months to 2 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai No.9 People's Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of Baseline Gesell Developmental Scale after 6 month | Neurobehavior effects | change in 6 months after surgery | |
| Secondary | change of Baseline Gesell Developmental Scale after 12 month | Neurobehavior effects | change in 12 months after surgery |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04291274 -
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）
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