Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant) (SEVODosage)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Rostock
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier:
NCT01896245
First received: July 5, 2013
Last updated: July 13, 2013
Last verified: July 2013
  Purpose

Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.


Condition Intervention
Vocal Cord Injuries
Drug: sevoflurane 0,8
Drug: sevoflurane 1,0
Drug: sevoflurane 1,2

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 Three Different Sevoflurane Concentrations (Without Muscle Relaxant)

Resource links provided by NLM:


Further study details as provided by University of Rostock:

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

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

Estimated Enrollment: 90
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevoflurane 0,8
sevoflurane 0,8: sevoflurane is administered with a concentration of 0,8 MAC
Drug: sevoflurane 0,8
anesthesia induction with propofol, remifentanil, and sevoflurane 0,8 MAC; afterwards tracheal intubation
Active Comparator: sevoflurane 1,0
sevoflurane 1,0: sevoflurane is administered with a concentration of 0,8 MAC
Drug: sevoflurane 1,0
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
Active Comparator: sevoflurane 1,2
sevoflurane 1,2: sevoflurane is administered with a concentration of 0,8 MAC
Drug: sevoflurane 1,2
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; 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
  • ASA I-III

Exclusion Criteria:

  • obesity
  • allergy against the study drugs
  • patients with a known or suspected difficult airway
  • diseases of the larynx
  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 ClinicalTrials.gov identifier: NCT01896245

Contacts
Contact: Thomas Mencke, Dr. +49 381 494 6411 thomas.mencke@googlemail.com
Contact: Ilona Bicker +49 381 494 6411 ilona.bicker@web.de

Locations
Germany
Department of Anesthesia and Intensive Care Medicine, University of Rostock Recruiting
Rostock, Mecklenburg/Vorpommern, Germany, 18057
Contact: Thomas Mencke         
Contact: Ilona Bicker         
Principal Investigator: Ilona Bicker         
Sub-Investigator: Refa Jacobs         
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Thomas Mencke, Dr. Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
  More Information

No publications provided

Responsible Party: Thomas Mencke, Clinical Associate Professor Dr Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01896245     History of Changes
Other Study ID Numbers: A 2013-0039
Study First Received: July 5, 2013
Last Updated: July 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
hoarseness
sore throat
intubating conditions
vocal cord injuries
sevoflurane

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on September 22, 2014