Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedJuly 3, 2012
June 1, 2012
1.2 years
June 7, 2012
June 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of vocal cord injuries
assessed by stroboscopy
24h after surgery
Secondary Outcomes (1)
incidence of hoarseness
24h after surgery
Study Arms (2)
Sevoflurane
ACTIVE COMPARATORAnesthesia was maintained with sevoflurane during surgery.
Anesthesia with propofol
ACTIVE COMPARATORAnesthesia was maintained with propofol during surgery.
Interventions
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Maintenance of anesthesia with propofol
Eligibility Criteria
You may qualify if:
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
You may not qualify if:
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Thomas Mencke
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 12, 2012
Study Start
August 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
July 3, 2012
Record last verified: 2012-06