Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
Primary Purpose
Vocal Cord; Injury, Superficial
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sevoflurane
propofol
Sponsored by
About this trial
This is an interventional prevention trial for Vocal Cord; Injury, Superficial focused on measuring hoarseness, sore throat, vocal cord injuries
Eligibility Criteria
Inclusion Criteria:
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
Exclusion Criteria:
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
Sites / Locations
- University of Rostock
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sevoflurane
Anesthesia with propofol
Arm Description
Anesthesia was maintained with sevoflurane during surgery.
Anesthesia was maintained with propofol during surgery.
Outcomes
Primary Outcome Measures
incidence of vocal cord injuries
assessed by stroboscopy
Secondary Outcome Measures
incidence of hoarseness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01616966
Brief Title
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
Official Title
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord; Injury, Superficial
Keywords
hoarseness, sore throat, vocal cord injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with sevoflurane during surgery.
Arm Title
Anesthesia with propofol
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with propofol during surgery.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
remifentanil
Intervention Description
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
remifentanil
Intervention Description
Maintenance of anesthesia with propofol
Primary Outcome Measure Information:
Title
incidence of vocal cord injuries
Description
assessed by stroboscopy
Time Frame
24h after surgery
Secondary Outcome Measure Information:
Title
incidence of hoarseness
Time Frame
24h after surgery
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:
orotracheal intubation
surgery of the ear
written consent
ASA I-III
Exclusion Criteria:
preexisting pathologies of the vocal cords
obesity
difficult airway
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
Mecklenburg/Vorpommern
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
We'll reach out to this number within 24 hrs