Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier:
NCT01616966
First received: June 7, 2012
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Rostock:

Primary Outcome Measures:
  • incidence of vocal cord injuries [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]
    assessed by stroboscopy


Secondary Outcome Measures:
  • incidence of hoarseness [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • orotracheal intubation
  • surgery of the ear
  • written consent
  • ASA I-III

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 ClinicalTrials.gov identifier: NCT01616966

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, University of Rostock
ClinicalTrials.gov Identifier: NCT01616966     History of Changes
Other Study ID Numbers: A 2010 29
Study First Received: June 7, 2012
Last Updated: June 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 25, 2014