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Completed

NCT Number: NCT01896245

Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)

Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.

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Key information

Conditions

Other Specified Injuries of Vocal Cord, Sequela 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

Department of Anesthesia and Intensive Care Medicine, University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

About this study

We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.

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
  • ASA I-III

Exclusion criteria

  • obesity
  • allergy against the study drugs
  • patients with a known or suspected difficult airway
  • diseases of the larynx

Treatment and study plan

sevoflurane 1,0

Drug

anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation

Other names: sevo 2,0 %

sevoflurane 1,2

Drug

anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation

Other names: sevo 2,5 %

sevoflurane 1,4

Drug

anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation

Other names: sevo 3,0 %

Primary outcomes

  1. incidence of vocal cord injuries

    Time frame: 24 hours after tracheal intubation

Secondary outcomes

  1. incidence of hoarseness

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

  2. incidence of soar throat

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

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Acronym: SEVODosage

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Oct 6, 2014

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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