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OpenTrials
Completed

NCT Number: NCT00525551

Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

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.

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Key information

Conditions

Otosclerosis Ear Diseases Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska University Hospital Huddinge, Huddinge, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetylcysteine

Drug

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.

placebo (NaCl)

Drug

300 mL 0.9% NaCl

Primary outcomes

  1. Hearing thresholds

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • AstraZeneca
  • Karolinska Institutet

Registry information

Official study title

Acetylcystein Vid Stapedotomi

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2007
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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