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Clinical Trials/NCT01896245
NCT01896245
Completed
Not Applicable

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

University of Rostock1 site in 1 country90 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
sevoflurane 1,0
Conditions
Other Specified Injuries of Vocal Cord, Sequela
Sponsor
University of Rostock
Enrollment
90
Locations
1
Primary Endpoint
incidence of vocal cord injuries
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Thomas Mencke

Clinical Associate Professor Dr Thomas Mencke

University of Rostock

Eligibility Criteria

Inclusion Criteria

  • ear-nose-throat surgery
  • orotracheal intubation for surgery of the ear
  • ASA I-III

Exclusion Criteria

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

Arms & Interventions

sevoflurane 1,0

sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC

Intervention: sevoflurane 1,0

sevoflurane 1,2

sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC

Intervention: sevoflurane 1,2

sevoflurane 1,4

sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC

Intervention: sevoflurane 1,4

Outcomes

Primary Outcomes

incidence of vocal cord injuries

Time Frame: 24 hours after tracheal intubation

Secondary Outcomes

  • incidence of soar throat(24, 48, and 72 hours after tracheal intubation)
  • incidence of hoarseness(24, 48, and 72 hours after tracheal intubation)

Study Sites (1)

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