Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Study Overview
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Brief Summary
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The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.

Detailed Description
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The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.

Official Title
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Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Drug: Intracochlear Dexamethasone
* Drug: Intratympanic Dexamethasone
* Drug: No additional drugs(control Group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with sensorineural hearing loss Patients who will have cochlear implant surgery with CI422 electrode Exclusion Criteria: Patients with cochlear abnormality Patients with auditory neuropathy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>intracochlear dexamethasone application during cochlear implantation | Drug: Intracochlear Dexamethasone<br>* intracochlear injection of dexamethasone with cochlear implantation<br>* Other names: intracochlear;|
| Active Comparator: Group 2<br>intratympanic dexamethasone application during cochlear implantation | Drug: Intratympanic Dexamethasone<br>* intratympanic injection of dexamethasone with cochlear implantation<br>* Other names: intratympanic;|
| Sham Comparator: Group 3<br>No drugs during cochlear implantation | Drug: No additional drugs(control Group)<br>* Control group: No drugs will be injected middle ear with cochlear implantation<br>* Other names: No drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrode Impedance(Ohm) | All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months | 1-3 months | 
| Electrode thresholds(CL) | All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months | 1-3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, cochlear implant