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Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier:
NCT01591031
First received: April 27, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Laryngeal Injuries
 Drug: Sevoflurane
Drug: Rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • incidence of vocal cord injuries [ Time Frame: 24 h after tracheal intubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of hoarseness [ Time Frame: 24h, 48 h, and 72 h after tracheal intubation ] [ Designated as safety issue: No ]
  • incidence of soar throat [ Time Frame: 24h, 48h, and 72 h after tracheal intubation ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevoflurane
anesthesia induction with propofol, remifentanil and sevoflurane
 Drug: Sevoflurane
anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
Active Comparator: rocuronium
anesthesia induction with propofol, remifentanil and rocuronium
 Drug: Rocuronium
anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591031

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

No publications provided

Responsible Party: Thomas Mencke, Principal Invastigator, Clinical Associate Professor, Dr. Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01591031     History of Changes
Other Study ID Numbers: A 2011 124
Study First Received: April 27, 2012
Last Updated: February 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
laryngeal injuries
vocal cord injuries
hoarseness
sore throat

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Remifentanil
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Opioid
Analgesics
Sensory System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on May 16, 2013