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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591031
First Posted: May 3, 2012
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock
  Purpose
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.

Condition Intervention
Laryngeal Injuries Drug: Sevoflurane Drug: Rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Thomas Mencke, University of Rostock:

Primary Outcome Measures:
  • incidence of vocal cord injuries [ Time Frame: 24 h after tracheal intubation ]

Secondary Outcome Measures:
  • incidence of hoarseness [ Time Frame: 24h, 48 h, and 72 h after tracheal intubation ]
  • incidence of soar throat [ Time Frame: 24h, 48h, and 72 h after tracheal intubation ]

Enrollment: 60
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevoflurane
anesthesia induction with propofol, remifentanil and sevoflurane
Drug: Sevoflurane
anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
Active Comparator: rocuronium
anesthesia induction with propofol, remifentanil and rocuronium
Drug: Rocuronium
anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591031


Locations
Germany
University of Rostock
Rostock, Mecklenburg/Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Mencke, Principal Invastigator, Clinical Associate Professor, Dr. Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01591031     History of Changes
Other Study ID Numbers: A 2011 124
First Submitted: April 27, 2012
First Posted: May 3, 2012
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Thomas Mencke, University of Rostock:
laryngeal injuries
vocal cord injuries
hoarseness
sore throat

Additional relevant MeSH terms:
Wounds and Injuries
Anesthetics
Propofol
Remifentanil
Sevoflurane
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents