- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616966
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
June 29, 2012 updated by: Thomas Mencke, University of Rostock
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
65
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
-
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:
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
Exclusion Criteria:
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
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 was maintained with sevoflurane during surgery.
|
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Other Names:
|
Active Comparator: Anesthesia with propofol
Anesthesia was maintained with propofol during surgery.
|
Maintenance of anesthesia with propofol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of vocal cord injuries
Time Frame: 24h after surgery
|
assessed by stroboscopy
|
24h after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of hoarseness
Time Frame: 24h after surgery
|
24h after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 7, 2012
First Submitted That Met QC Criteria
June 11, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Estimate)
July 3, 2012
Last Update Submitted That Met QC Criteria
June 29, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Remifentanil
- Propofol
- Sevoflurane
Other Study ID Numbers
- A 2010 29
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.
Clinical Trials on Vocal Cord; Injury, Superficial
-
Assiut UniversityUnknown
-
University of ManitobaCompletedVocal Cord Paresis | Acquired Vocal Cord PalsyCanada
-
Lawson Health Research InstituteUnknownUnilateral Vocal Cord LesionsCanada
-
Tel-Aviv Sourasky Medical CenterRecruitingVocal Fold Polyp | Vocal Cord Cyst | Vocal Nodules in AdultsIsrael
-
Icahn School of Medicine at Mount SinaiNeuroVisionCompletedVocal Cord Function in Neck ProceduresUnited States
-
Thomas SchrickerMerck Sharp & Dohme LLCTerminatedHigh-Frequency Jet Ventilation | Vocal Cord ResectionCanada
-
University of PittsburghMassachusetts Eye and Ear InfirmaryCompletedDisorder of Vocal CordUnited States
-
Jacqueline Gartner-SchmidtCompletedVocal Fold Polyp | Vocal Cord Cyst | Voice and Resonance Disorders | Vocal Cord Polyp | Atrophy of Vocal CordUnited States
-
The R2 InstituteUnknownVocal Cord Tension | Dysfluency DevelopmentalUnited States
-
University of FloridaCompletedUnilateral Vocal Cord Paralysis | Unilateral Vocal Cord ParesisUnited States
Clinical Trials on Sevoflurane
-
Yeungnam University College of MedicineCompleted
-
University of RostockCompletedOther Specified Injuries of Vocal Cord, SequelaGermany
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceTerminated
-
Kocaeli Derince Education and Research HospitalCompleted
-
Pontificia Universidad Catolica de ChileUnknown
-
Universiti Sains MalaysiaCompletedGeneral Anaesthesia | PaediatricsMalaysia
-
University Hospital, Clermont-FerrandCompleted
-
University Hospital, GhentCompleted
-
China International Neuroscience InstitutionCompletedGeneral Anesthesia | Urinary SurgeryChina