NCT01591031CompletedNot Applicable
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
University of Rostock1 site in 1 country60 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- incidence of vocal cord injuries
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ear-nose-throat surgery
- •orotracheal intubation for surgery of the ear
Exclusion Criteria
- •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
Arms & Interventions
sevoflurane
Active Comparator
anesthesia induction with propofol, remifentanil and sevoflurane
Intervention: Sevoflurane (Drug)
rocuronium
Active Comparator
anesthesia induction with propofol, remifentanil and rocuronium
Intervention: Rocuronium (Drug)
Outcomes
Primary Outcomes
incidence of vocal cord injuries
Time Frame: 24 h after tracheal intubation
Secondary Outcomes
- incidence of hoarseness(24h, 48 h, and 72 h after tracheal intubation)
- incidence of soar throat(24h, 48h, and 72 h after tracheal intubation)
Investigators
Thomas Mencke
Principal Invastigator, Clinical Associate Professor, Dr. Thomas Mencke
University of Rostock
Study Sites (1)
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