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CompletedNCT01591031Updated Feb 15, 2013

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

An interventional study of Sevoflurane and Rocuronium in Laryngeal Injuries, sponsored by University of Rostock. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by University of Rostock · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Laryngeal Injuries

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Keywords

  • laryngeal injuries
  • vocal cord injuries
  • hoarseness
  • sore throat
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 60 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of Rostock is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ear-nose-throat surgery
  • orotracheal intubation for surgery of the ear

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    sevoflurane

    anesthesia induction with propofol, remifentanil and sevoflurane

    Drug: Sevoflurane

  • Active comparator
    rocuronium

    anesthesia induction with propofol, remifentanil and rocuronium

    Drug: Rocuronium

Interventions

  • DrugSevoflurane

    anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation

  • DrugRocuronium

    anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation

06

What researchers measure

Primary outcomes

  1. incidence of vocal cord injuries

    Time frame: 24 h after tracheal intubation

Secondary outcomes

  1. incidence of hoarseness

    Time frame: 24h, 48 h, and 72 h after tracheal intubation

  2. incidence of soar throat

    Time frame: 24h, 48h, and 72 h after tracheal intubation

07

Study locations

1 site
  • University of Rostock
    Rostock, Mecklenburg/Vorpommern 18057, Germany
08

References and documents

Publications

  • 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. PubMed 24860256 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01591031
Lead sponsor
University of Rostock
Responsible party
Thomas Mencke (Principal Invastigator, Clinical Associate Professor, Dr. Thomas Mencke, University of Rostock) — Principal investigator
First posted
May 3, 2012
Start date
Apr 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Feb 15, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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