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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896245

Acronym

SEVODosage

Enrollment

Registered

2013-07-11

Start date

2013-07-31

Completion date

2014-09-30

Last updated

2014-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Specified Injuries of Vocal Cord, Sequela

Keywords

hoarseness, sore throat, intubating conditions, vocal cord injuries, sevoflurane

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.

Interventions

DRUGsevoflurane 1,0

anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation

DRUGsevoflurane 1,2

anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation

DRUGsevoflurane 1,4

anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
incidence of vocal cord injuries	24 hours after tracheal intubation

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026