Randomised Placebo controlled trial on Systemic Steroids to protect the Inner ear during Cochlear Implant Surgery
- Conditions
- Ear healthEar - Deafness
- Registration Number
- ACTRN12619000120178
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Research question: Whether a patient's acoustic ("normal") hearing could be protected by administering by injection a steroid medication (methylprednisolone) in a high dose during the cochlear implant operation. Background: The preservation of hearing is a goal of cochlear implantation, so that normal hearing can be used together with the cochlear-implant-driven "electrical" hearing. This combination improves hearing outcomes, especially in the presence of background noise. Participants: Adults undergoing cochlear implantation, with measurable hearing on their pre-operative hearing test (85 dB or better at 500 Hz). Main finding: The steroid injection did not improve the preservation of patients' hearing at either 3 or 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 108
Aged between 18 & 80 years of age at time of inclusion into the trial
85dB or better pure tone threshold (dBnHL) at 500Hz
1. Note medically suitable due to past history of psychosis (mental illness), poorly controlled Type I diabetes, or known adverse reaction to steroids
2. Patients with poorly controlled hypertension, poorly controlled Type II diabetes or active gastro-oesophageal reflux will require medical clearance from the Department of Anaesthesia, or the responsible anaesthetist. Note: such individuals will require medical stabilisation prior to being fit for anaesthesia, so it would be appropriate to determine trial suitability from the anaesthetist when the preoperative medical workup is being undertaken
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method