The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Long Term Neurobehavioral Effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Short time anesthesia group

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

No interventions assigned to this group

Long time anesthesia group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No