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

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.
 
ClinicalTrials.gov Identifier: NCT01591031
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
incidence of vocal cord injuries [ Time Frame: 24 h after tracheal intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01591031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
Official Title  ICMJE Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Laryngeal Injuries
Intervention  ICMJE
  • Drug: Sevoflurane
    anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
  • Drug: Rocuronium
    anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
Study Arms  ICMJE
  • Active Comparator: sevoflurane
    anesthesia induction with propofol, remifentanil and sevoflurane
    Intervention: Drug: Sevoflurane
  • Active Comparator: rocuronium
    anesthesia induction with propofol, remifentanil and rocuronium
    Intervention: Drug: Rocuronium
Publications * Mencke T, Jacobs RM, Machmueller S, Sauer M, Heidecke C, Kallert A, Pau HW, Noeldge-Schomburg G, Ovari A. Intubating conditions and side effects of propofol, remifentanil and sevoflurane compared with propofol, remifentanil and rocuronium: a randomised, prospective, clinical trial. BMC Anesthesiol. 2014 May 22;14:39. doi: 10.1186/1471-2253-14-39. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591031
Other Study ID Numbers  ICMJE A 2011 124
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Mencke, University of Rostock
Study Sponsor  ICMJE University of Rostock
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rostock
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP