The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment

March 5, 2020 updated by: Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lei Zhang, Ph.D

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai No.9 People's Hospital
        • Contact:
          • Hong Jiang, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing cochlear implantation under general anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Short time anesthesia group
Unilateral cochlear implantation,which time of anesthesia is less than 3 hours
Long time anesthesia group
Bilateral cochlear implantation, which time of anesthesia is more than 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Baseline Gesell Developmental Scale after 6 month
Time Frame: change in 6 months after surgery
Neurobehavior effects
change in 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Baseline Gesell Developmental Scale after 12 month
Time Frame: change in 12 months after surgery
Neurobehavior effects
change in 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Study Chair: Jingjie Li, M.D, Shanghai No.9 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2019-T19-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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