Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
Primary Purpose
Laryngeal Injuries
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sevoflurane
Rocuronium
Sponsored by
About this trial
This is an interventional prevention trial for Laryngeal Injuries focused on measuring laryngeal injuries, vocal cord injuries, hoarseness, sore throat
Eligibility Criteria
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
Sites / Locations
- University of Rostock
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
sevoflurane
rocuronium
Arm Description
anesthesia induction with propofol, remifentanil and sevoflurane
anesthesia induction with propofol, remifentanil and rocuronium
Outcomes
Primary Outcome Measures
incidence of vocal cord injuries
Secondary Outcome Measures
incidence of hoarseness
incidence of soar throat
Full Information
NCT ID
NCT01591031
First Posted
April 27, 2012
Last Updated
February 13, 2013
Sponsor
University of Rostock
1. Study Identification
Unique Protocol Identification Number
NCT01591031
Brief Title
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
Official Title
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Injuries
Keywords
laryngeal injuries, vocal cord injuries, hoarseness, sore throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
anesthesia induction with propofol, remifentanil and sevoflurane
Arm Title
rocuronium
Arm Type
Active Comparator
Arm Description
anesthesia induction with propofol, remifentanil and rocuronium
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
Primary Outcome Measure Information:
Title
incidence of vocal cord injuries
Time Frame
24 h after tracheal intubation
Secondary Outcome Measure Information:
Title
incidence of hoarseness
Time Frame
24h, 48 h, and 72 h after tracheal intubation
Title
incidence of soar throat
Time Frame
24h, 48h, and 72 h after tracheal intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
Mecklenburg/Vorpommern
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24860256
Citation
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.
Results Reference
derived
Learn more about this trial
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
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