Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol

This study has been completed.
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock Identifier:
First received: June 7, 2012
Last updated: June 29, 2012
Last verified: June 2012
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.

Condition Intervention
Vocal Cord; Injury, Superficial
Drug: Sevoflurane
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Thomas Mencke, University of Rostock:

Primary Outcome Measures:
  • incidence of vocal cord injuries [ Time Frame: 24h after surgery ]
    assessed by stroboscopy

Secondary Outcome Measures:
  • incidence of hoarseness [ Time Frame: 24h after surgery ]

Enrollment: 65
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevoflurane
Anesthesia was maintained with sevoflurane during surgery.
Drug: Sevoflurane
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Other Name: remifentanil
Active Comparator: Anesthesia with propofol
Anesthesia was maintained with propofol during surgery.
Drug: propofol
Maintenance of anesthesia with propofol
Other Name: remifentanil

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • orotracheal intubation
  • surgery of the ear
  • written consent

Exclusion Criteria:

  • preexisting pathologies of the vocal cords
  • obesity
  • difficult airway
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01616966

University of Rostock
Rostock, Mecklenburg/Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
  More Information

Responsible Party: Thomas Mencke, University of Rostock Identifier: NCT01616966     History of Changes
Other Study ID Numbers: A 2010 29
Study First Received: June 7, 2012
Last Updated: June 29, 2012

Keywords provided by Thomas Mencke, University of Rostock:
sore throat
vocal cord injuries

Additional relevant MeSH terms:
Wounds and Injuries
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation processed this record on May 25, 2017