None listed
Conditions
Brief summary
This study aims to determine whether steroid (medication) delivered directly through an intravenous cannula before cochlear implant operation will better protect ear function during and after the operation.
Interventions
a slow intravenous injection of Methylprednisolone 13.5mg/kg (1000mg total dose for an average body weight 75Kg) over 10 minutes will be infused through an intravenous cannula 60 minutes prior to surgery.
This procedure will be monitored by the clinical trial coordinator.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Aged between 18 & 80 years of age at time of inclusion into the trial 85dB or better pure tone threshold (dBnHL) at 500Hz
Exclusion criteria
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
Outcome results
None listed