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

U

University of Rostock

Status

Completed

Conditions

Other Specified Injuries of Vocal Cord, Sequela

Treatments

Drug: sevoflurane 1,4
Drug: sevoflurane 1,0
Drug: sevoflurane 1,2

Study type

Interventional

Funder types

Other

Identifiers

NCT01896245
A 2013-0039

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups

sevoflurane 1,0
Active Comparator group
Description:
sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
Treatment:
Drug: sevoflurane 1,0
sevoflurane 1,2
Active Comparator group
Description:
sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC
Treatment:
Drug: sevoflurane 1,2
sevoflurane 1,4
Active Comparator group
Description:
sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
Treatment:
Drug: sevoflurane 1,4

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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