Antioxidants in stapedotomy
type: Dataset
description: Background: Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies. Methods: We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo. Findings: One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed) and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p=0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting. Conclusions: N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy Purpose: Otosclerosis is a disease of the middle ear that causes gradually increasing hearing loss. The stapes is gradually fixed inside the oval window, which leads to hear…
citation: Fridberger A. A randomised, double blind trial of N-acetylcysteine for hearing protection during stapes surgery. PLOS One 2014, In press.
conditions of access: http://publications.europa.eu/resource/authority/access-right/PUBLIC
conditions of access: info:eu-repo/semantics/openAccess
creative work status: completed
  type: DefinedTerm
  in defined term set: http://publications.europa.eu/resource/authority/dataset-status
  term code: COMPLETED
creator: Anders Fridberger
  type: Person
  affiliation: Linköping University
  family name: Fridberger
  given name: Anders
date modified: 2017-01-02
date published: 2014-12-19
language: English
is part of: https://doi.org/10.5878/002561
keywords: HEALTH
keywords: Medical and Health Sciences
  type: DefinedTerm
  term code: 3
keywords: Neurosciences
  type: DefinedTerm
  term code: 30105
keywords: Hearing
keywords: Hearing Loss
keywords: Ear Diseases
keywords: Antioxidants
keywords: Otosclerosis
keywords: stapedotomy
keywords: prevention
publisher: Linköping University
size: QuantitativeValue
  unit text: cases
  value: 145
size: QuantitativeValue
  unit text: variables
  value: 9
temporal coverage: 2007-12-01/2013-04-30
distribution: data/SND 0974-001-v1.zip
  type: DataDownload
  additional type: data
  conditions of access: http://publications.europa.eu/resource/authority/access-right/PUBLIC
  conditions of access: info:eu-repo/semantics/openAccess
  content size: 121931
  encoding format: application/zip
distribution: documentation/0974-001CB.pdf
  type: DataDownload
  additional type: documentation
  conditions of access: http://publications.europa.eu/resource/authority/access-right/PUBLIC
  conditions of access: info:eu-repo/semantics/openAccess
  content size: 106238
  encoding format: application/pdf
version: 1.0

PropertyValue
property ID: DOI
value: 10.5878/002570

Linköping University
type: Organization
department: Department of Clinical and Experimental Medicine, IKE

English
type: Language
alternate name: eng

HEALTH
type: DefinedTerm
term code: Health

Hearing
type: DefinedTerm
description: The ability or act of sensing and transducing ACOUSTIC STIMULATION to the CENTRAL NERVOUS SYSTEM. It is also called audition.
term code: D006309

Hearing Loss
type: DefinedTerm
description: A general term for the complete or partial loss of the ability to hear from one or both ears.
term code: D034381

Ear Diseases
type: DefinedTerm
description: Pathological processes of the ear, the hearing, and the equilibrium system of the body.
term code: D004427

Antioxidants
type: DefinedTerm
description: Naturally occurring or synthetic substances that inhibit or retard oxidation reactions. They counteract the damaging effects of oxidation in animal tissues.
term code: D000975

Otosclerosis
type: DefinedTerm
description: Formation of spongy bone in the labyrinth capsule which can progress toward the STAPES (stapedial fixation) or anteriorly toward the COCHLEA leading to conductive, sensorineural, or mixed HEARING LOSS. Several genes are associated with familial otosclerosis with varied clinical signs.
term code: D010040