The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

Shanghai Jiao Tong University

Status: Unknown

Conditions: Long Term Neurobehavioral Effects

Study type: Observational

Funder types: Other

Identifiers

NCT04255485

SH9H-2019-T19-2

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 unilateral or bilateral cochlear implantation.

Enrollment: 52 estimated patients

Sex: All

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 2 patient groups

Short time anesthesia group

Description:

Unilateral cochlear implantation,which time of anesthesia is less than 3 hours

Long time anesthesia group

Description:

Bilateral cochlear implantation, which time of anesthesia is more than 3 hours