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Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant) (SEVODosage)

Primary Purpose

Other Specified Injuries of Vocal Cord, Sequela

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sevoflurane 1,0
sevoflurane 1,2
sevoflurane 1,4
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Specified Injuries of Vocal Cord, Sequela focused on measuring hoarseness, sore throat, intubating conditions, vocal cord injuries, sevoflurane

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
  • ASA I-III

Exclusion Criteria:

  • obesity
  • allergy against the study drugs
  • patients with a known or suspected difficult airway
  • diseases of the larynx

Sites / Locations

  • Department of Anesthesia and Intensive Care Medicine, University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

sevoflurane 1,0

sevoflurane 1,2

sevoflurane 1,4

Arm Description

sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC

sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC

sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC

Outcomes

Primary Outcome Measures

incidence of vocal cord injuries

Secondary Outcome Measures

incidence of hoarseness
incidence of soar throat

Full Information

First Posted
July 5, 2013
Last Updated
October 3, 2014
Sponsor
University of Rostock
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1. Study Identification

Unique Protocol Identification Number
NCT01896245
Brief Title
Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Acronym
SEVODosage
Official Title
Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (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 and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.
Detailed Description
We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Specified Injuries of Vocal Cord, Sequela
Keywords
hoarseness, sore throat, intubating conditions, vocal cord injuries, sevoflurane

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
sevoflurane 1,0
Arm Type
Active Comparator
Arm Description
sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
Arm Title
sevoflurane 1,2
Arm Type
Active Comparator
Arm Description
sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC
Arm Title
sevoflurane 1,4
Arm Type
Active Comparator
Arm Description
sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
Intervention Type
Drug
Intervention Name(s)
sevoflurane 1,0
Other Intervention Name(s)
sevo 2,0 %
Intervention Description
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
Intervention Type
Drug
Intervention Name(s)
sevoflurane 1,2
Other Intervention Name(s)
sevo 2,5 %
Intervention Description
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
Intervention Type
Drug
Intervention Name(s)
sevoflurane 1,4
Other Intervention Name(s)
sevo 3,0 %
Intervention Description
anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
Primary Outcome Measure Information:
Title
incidence of vocal cord injuries
Time Frame
24 hours after tracheal intubation
Secondary Outcome Measure Information:
Title
incidence of hoarseness
Time Frame
24, 48, and 72 hours after tracheal intubation
Title
incidence of soar throat
Time Frame
24, 48, and 72 hours 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 ASA I-III Exclusion Criteria: obesity allergy against the study drugs patients with a known or suspected difficult airway diseases of the larynx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Mencke, Dr.
Organizational Affiliation
Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia and Intensive Care Medicine, University of Rostock
City
Rostock
State/Province
Mecklenburg/Vorpommern
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28449630
Citation
Ovari A, Bicker I, Machmueller S, Schuldt T, Sauer M, Soltesz S, Noeldge-Schomburg G, Mlynski R, Mencke T. Sevoflurane at 1.0 MAC together with remifentanil and propofol produces clinically acceptable intubation conditions at the vocal cords: A prospective randomized study. J Int Med Res. 2017 Jun;45(3):1098-1108. doi: 10.1177/0300060517701355. Epub 2017 Apr 28.
Results Reference
derived

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Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)

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