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Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04397354
Enrollment
34
Registered
2020-05-21
Start date
2020-03-02
Completion date
2022-09-20
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

Keywords

cochlear implant, dexamethasone

Brief summary

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

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.

Interventions

DRUGIntracochlear Dexamethasone

intracochlear injection of dexamethasone with cochlear implantation

intratympanic injection of dexamethasone with cochlear implantation

Control group: No drugs will be injected middle ear with cochlear implantation

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective, randomized

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Electrode Impedance(Ohm)1-3 monthsAll intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Electrode thresholds(CL)1-3 monthsAll intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026