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

October 3, 2014 updated by: Thomas Mencke, University of Rostock
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

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

  • Germany
    • Mecklenburg/Vorpommern
      • Rostock, Mecklenburg/Vorpommern, Germany, 18057
        • Department of Anesthesia and Intensive Care Medicine, 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:

  • 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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: sevoflurane 1,0
sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
Drug: sevoflurane 1,0
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
Other Names:
  • sevo 2,0 %
ACTIVE_COMPARATOR: sevoflurane 1,2
sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC
Drug: sevoflurane 1,2
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
Other Names:
  • sevo 2,5 %
ACTIVE_COMPARATOR: sevoflurane 1,4
sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
Drug: sevoflurane 1,4
anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
Other Names:
  • sevo 3,0 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of vocal cord injuries
Time Frame: 24 hours after tracheal intubation
24 hours after tracheal intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of hoarseness
Time Frame: 24, 48, and 72 hours after tracheal intubation
24, 48, and 72 hours after tracheal intubation
incidence of soar throat
Time Frame: 24, 48, and 72 hours after tracheal intubation
24, 48, and 72 hours after tracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Principal Investigator: Thomas Mencke, Dr., Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 3, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 2013-0039

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.

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