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Completed

NCT Number: NCT01591031

Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

Anesthesia induction with sevoflurane is not associated with an increased incidence or severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.

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Key information

Conditions

Laryngeal Injuries Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Voice Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ear-nose-throat surgery
  • orotracheal intubation for surgery of the ear

Exclusion criteria

  • obesity
  • allergy against the study drugs
  • patients with a known or suspected difficult airway (Mallampati score 3 or 4 and a mouth opening < 3.5 cm).
  • all patients were examined by stroboscopy one day before surgery and were excluded from the study when preexisting pathologies of the vocal cords were found

Treatment and study plan

Sevoflurane

Drug

anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation

Rocuronium

Drug

anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation

Primary outcomes

  1. incidence of vocal cord injuries

    Time frame: 24 h after tracheal intubation

Secondary outcomes

  1. incidence of hoarseness

    Time frame: 24h, 48 h, and 72 h after tracheal intubation

  2. incidence of soar throat

    Time frame: 24h, 48h, and 72 h after tracheal intubation

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 3, 2012
Registry last updated
Feb 15, 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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