Skip to main content
OpenTrials
Completed

NCT Number: NCT01616966

Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol

Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vocal Cord; Injury, Superficial 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 Wounds and Injuries

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

About this study

Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • orotracheal intubation
  • surgery of the ear
  • written consent
  • ASA I-III

Exclusion criteria

  • preexisting pathologies of the vocal cords
  • obesity
  • difficult airway

Treatment and study plan

Sevoflurane

Drug

Maintenance of anesthesia with sevoflurane 1.0 Vol%

Other names: remifentanil

Propofol

Drug

Maintenance of anesthesia with propofol

Other names: remifentanil

Primary outcomes

  1. incidence of vocal cord injuries

    Time frame: 24h after surgery

    assessed by stroboscopy

Secondary outcomes

  1. incidence of hoarseness

    Time frame: 24h after surgery

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 12, 2012
Registry last updated
Jul 3, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.