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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | intracochlear dexamethasone application during cochlear implantation |
|
| Group 2 | Active Comparator | intratympanic dexamethasone application during cochlear implantation |
|
| Group 3 | Sham Comparator | No drugs during cochlear implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracochlear Dexamethasone | Drug | intracochlear injection of dexamethasone with cochlear implantation |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fazil N Ardic, MD | Pamukkale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University | Denizli | 20070 | Turkey (Türkiye) |
The metadata will be shared by a public depository.
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069555 | Injection, Intratympanic |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Prospective, randomized
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| Intratympanic Dexamethasone | Drug | intratympanic injection of dexamethasone with cochlear implantation |
|
|
| No additional drugs(control Group) | Drug | Control group: No drugs will be injected middle ear with cochlear implantation |
|
|
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |