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

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ClinicalTrials.gov Identifier: NCT01896245
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Other Specified Injuries of Vocal Cord, Sequela Drug: sevoflurane 1,0 Drug: sevoflurane 1,2 Drug: sevoflurane 1,4

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Study Start Date : July 2013
Primary Completion Date : August 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Sevoflurane
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: sevoflurane 1,0
sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
Drug: sevoflurane 1,0
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
Other Name: sevo 2,0 %
Active Comparator: sevoflurane 1,2
sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC
Drug: sevoflurane 1,2
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
Other Name: sevo 2,5 %
Active Comparator: sevoflurane 1,4
sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
Drug: sevoflurane 1,4
anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
Other Name: sevo 3,0 %


Outcome Measures

Primary Outcome Measures :
  1. incidence of vocal cord injuries [ Time Frame: 24 hours after tracheal intubation ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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
  • ASA I-III

Exclusion Criteria:

  • obesity
  • allergy against the study drugs
  • patients with a known or suspected difficult airway
  • diseases of the larynx
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): NCT01896245


Locations
Germany
Department of Anesthesia and Intensive Care Medicine, University of Rostock
Rostock, Mecklenburg/Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Thomas Mencke, Dr. Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
More Information

Responsible Party: Thomas Mencke, Clinical Associate Professor Dr Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01896245     History of Changes
Other Study ID Numbers: A 2013-0039
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Muscle Hypotonia
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General