- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591031
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
February 13, 2013 updated by: Thomas Mencke, University of Rostock
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mecklenburg/Vorpommern
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Rostock, Mecklenburg/Vorpommern, Germany, 18057
- University of Rostock
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sevoflurane
anesthesia induction with propofol, remifentanil and sevoflurane
|
anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
|
Active Comparator: rocuronium
anesthesia induction with propofol, remifentanil and rocuronium
|
anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of vocal cord injuries
Time Frame: 24 h after tracheal intubation
|
24 h after tracheal intubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of hoarseness
Time Frame: 24h, 48 h, and 72 h after tracheal intubation
|
24h, 48 h, and 72 h after tracheal intubation
|
incidence of soar throat
Time Frame: 24h, 48h, and 72 h after tracheal intubation
|
24h, 48h, and 72 h after tracheal intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (Estimate)
May 3, 2012
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Sevoflurane
- Rocuronium
Other Study ID Numbers
- A 2011 124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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