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Clinical Trials/NCT01616966
NCT01616966
Completed
Not Applicable

Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial

University of Rostock1 site in 1 country65 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
Vocal Cord; Injury, Superficial
Sponsor
University of Rostock
Enrollment
65
Locations
1
Primary Endpoint
incidence of vocal cord injuries
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Thomas Mencke

Thomas Mencke

University of Rostock

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • preexisting pathologies of the vocal cords
  • difficult airway

Arms & Interventions

Sevoflurane

Anesthesia was maintained with sevoflurane during surgery.

Intervention: Sevoflurane

Anesthesia with propofol

Anesthesia was maintained with propofol during surgery.

Intervention: propofol

Outcomes

Primary Outcomes

incidence of vocal cord injuries

Time Frame: 24h after surgery

assessed by stroboscopy

Secondary Outcomes

  • incidence of hoarseness(24h after surgery)

Study Sites (1)

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