Otosclerosis
Conditions
Brief summary
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage. Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.
Interventions
DRUGAcetylcysteine
150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.
DRUGPlacebo (NaCl)
300 mL 0.9% NaCl
Sponsors
Karolinska Institutet
AstraZeneca
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Otosclerosis where surgery is planned * Air / bone gap larger than 20 dB * Normal middle ear status
Exclusion criteria
* Hypersensitivity to acetylcysteine * Deafness on the other ear * Stapedotomy previously performed on the ear * Pregnancy * Asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing thresholds | one year |
Countries
Sweden
Outcome results
None listed