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

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ClinicalTrials.gov Identifier: NCT01616966
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vocal Cord; Injury, Superficial Drug: Sevoflurane Drug: propofol Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : August 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Sevoflurane
Anesthesia was maintained with sevoflurane during surgery.
Drug: Sevoflurane
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Other Name: remifentanil
Active Comparator: Anesthesia with propofol
Anesthesia was maintained with propofol during surgery.
Drug: propofol
Maintenance of anesthesia with propofol
Other Name: remifentanil



Primary Outcome Measures :
  1. incidence of vocal cord injuries [ Time Frame: 24h after surgery ]
    assessed by stroboscopy


Secondary Outcome Measures :
  1. incidence of hoarseness [ Time Frame: 24h after surgery ]


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:

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

Exclusion Criteria:

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

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): NCT01616966


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

Responsible Party: Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01616966     History of Changes
Other Study ID Numbers: A 2010 29
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Wounds and Injuries
Anesthetics
Propofol
Remifentanil
Sevoflurane
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