Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Pamukkale University

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Drug: Intratympanic Dexamethasone; Drug: No additional drugs(control Group); Drug: Intracochlear Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04397354

2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Group 1

Active Comparator group

Description:

intracochlear dexamethasone application during cochlear implantation

Treatment:

Drug: Intracochlear Dexamethasone

Group 2

Active Comparator group

Description:

intratympanic dexamethasone application during cochlear implantation

Treatment:

Drug: Intratympanic Dexamethasone

Group 3

Sham Comparator group

Description:

No drugs during cochlear implantation

Treatment:

Drug: No additional drugs(control Group)