search
Back to results

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

Primary Purpose

Vocal Cord; Injury, Superficial

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sevoflurane
propofol
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vocal Cord; Injury, Superficial focused on measuring hoarseness, sore throat, vocal cord injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • preexisting pathologies of the vocal cords
  • obesity
  • difficult airway

Sites / Locations

  • University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sevoflurane

Anesthesia with propofol

Arm Description

Anesthesia was maintained with sevoflurane during surgery.

Anesthesia was maintained with propofol during surgery.

Outcomes

Primary Outcome Measures

incidence of vocal cord injuries
assessed by stroboscopy

Secondary Outcome Measures

incidence of hoarseness

Full Information

First Posted
June 7, 2012
Last Updated
June 29, 2012
Sponsor
University of Rostock
search

1. Study Identification

Unique Protocol Identification Number
NCT01616966
Brief Title
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord; Injury, Superficial
Keywords
hoarseness, sore throat, vocal cord injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with sevoflurane during surgery.
Arm Title
Anesthesia with propofol
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with propofol during surgery.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
remifentanil
Intervention Description
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
remifentanil
Intervention Description
Maintenance of anesthesia with propofol
Primary Outcome Measure Information:
Title
incidence of vocal cord injuries
Description
assessed by stroboscopy
Time Frame
24h after surgery
Secondary Outcome Measure Information:
Title
incidence of hoarseness
Time Frame
24h after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
Mecklenburg/Vorpommern
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs