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Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

Primary Purpose

Laryngeal Injuries

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

About this trial

This is an interventional prevention trial for Laryngeal Injuries focused on measuring laryngeal injuries, vocal cord injuries, hoarseness, sore throat

Eligibility Criteria

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

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

Sites / Locations

  • University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sevoflurane

rocuronium

Arm Description

anesthesia induction with propofol, remifentanil and sevoflurane

anesthesia induction with propofol, remifentanil and rocuronium

Outcomes

Primary Outcome Measures

incidence of vocal cord injuries

Secondary Outcome Measures

incidence of hoarseness
incidence of soar throat

Full Information

First Posted
April 27, 2012
Last Updated
February 13, 2013
Sponsor
University of Rostock
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1. Study Identification

Unique Protocol Identification Number
NCT01591031
Brief Title
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
Official Title
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Injuries
Keywords
laryngeal injuries, vocal cord injuries, hoarseness, sore throat

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
anesthesia induction with propofol, remifentanil and sevoflurane
Arm Title
rocuronium
Arm Type
Active Comparator
Arm Description
anesthesia induction with propofol, remifentanil and rocuronium
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
Primary Outcome Measure Information:
Title
incidence of vocal cord injuries
Time Frame
24 h after tracheal intubation
Secondary Outcome Measure Information:
Title
incidence of hoarseness
Time Frame
24h, 48 h, and 72 h after tracheal intubation
Title
incidence of soar throat
Time Frame
24h, 48h, and 72 h after tracheal intubation

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: 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
Facility Information:
Facility Name
University of Rostock
City
Rostock
State/Province
Mecklenburg/Vorpommern
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24860256
Citation
Mencke T, Jacobs RM, Machmueller S, Sauer M, Heidecke C, Kallert A, Pau HW, Noeldge-Schomburg G, Ovari A. Intubating conditions and side effects of propofol, remifentanil and sevoflurane compared with propofol, remifentanil and rocuronium: a randomised, prospective, clinical trial. BMC Anesthesiol. 2014 May 22;14:39. doi: 10.1186/1471-2253-14-39. eCollection 2014.
Results Reference
derived

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Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

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