Antioxidants during stapedotomy

Creator/Principal investigator(s)

Anders Fridberger - Linköping University, Department of Clinical and Experimental Medicine, IKE

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 outco

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Principal organisation

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Responsible department/unit

Linköping University, Department of Clinical and Experimental Medicine, IKE

Creator/Principal investigator(s)

Anders Fridberger - Linköping University, Department of Clinical and Experimental Medicine, IKE

Identifiers

SND-ID: SND 0974

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 outco

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Language

English

Time period(s) investigated

2007-12-01 — 2013-04-30

Geographic spread

Geographic description: Stockholm, Uppsala

Unit of analysis

Population

Patients who had surgery for otosclerosis at Karolinska University Hospital in Solna and Huddinge, and at Uppsala University Hospital.

Sampling procedure

Probability: Stratified

Ethics Review

Stockholm — Ref. 2007/305-31

Associated documentation

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Publications

Fridberger A. A randomised, double blind trial of N-acetylcysteine for hearing protection during stapes surgery. PLOS One 2014, In press.

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Version 1.0

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Antioxidants in stapedotomy

Suggested citation

Anders Fridberger. Linköping University, Department of Clinical and Experimental Medicine, IKE (2014). <em>Antioxidants in stapedotomy</em>. Swedish National Data Service. Version 1.0. <a href="https://doi.org/10.5878/002570">https://doi.org/10.5878/002570</a>

Creator/Principal investigator(s)

Anders Fridberger - Linköping University, Department of Clinical and Experimental Medicine, IKE

Description

The dataset contains 9 variables:
"id" is a number with range 1 - 145, unique for each patient.
"medicin" denotes the type of treatment given (possible values are "N-Acetylcysteine" or "Placebo").
"beta" denotes whether the steroid betametason was given before surgery.
"gender" is "f" for female patients and "m" for males.
"weight" is each patient's weight in kg.
"age" is the age (in years, at the time of surgery).
"freq" denotes the type of measurement performed. There are several possible valu

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Data format / data structure

Numeric

Data collection

Mode of collection: Physical measurements and tests

Time period(s) for data collection: 2007-12-01 — 2013-04-30

Data collector: Karolinska university Hospital and Uppsala University Hospital

Source of the data: Population group

Time period(s) investigated

2007-12-01 — 2013-04-30

Variables

9

Number of individuals/objects

145

Published: 2015-01-08
Last updated: 2017-01-02