Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Drug: Intracochlear Dexamethasone; Drug: No additional drugs(control Group); Drug: Intratympanic Dexamethasone

• Registration Number: NCT04397354
• Lead Sponsor: Pamukkale University

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.

Study Timeline

• Study Start: 2020-03-02
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-17
• Study First Posted: 2020-05-21
• Status Verified: 2022-06
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-20
• Last Update Submitted: 2023-01-01
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Intracochlear Dexamethasone	intracochlear dexamethasone application during cochlear implantation
Group 3	No additional drugs(control Group)	No drugs during cochlear implantation
Group 2	Intratympanic Dexamethasone	intratympanic dexamethasone application during cochlear implantation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey