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

Other Specified Injuries of Vocal Cord, Sequela Clinical Trial

— SEVODosage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896245
• Other study ID #: A 2013-0039
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: October 3, 2014
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Muscle Hypotonia
• Other Specified Injuries of Vocal Cord, Sequela

Intervention

Drug:
• sevoflurane 1,0
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
• sevoflurane 1,2
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
• sevoflurane 1,4
anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation

Locations

Country	Name	City	State
Germany	Department of Anesthesia and Intensive Care Medicine, University of Rostock	Rostock	Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of vocal cord injuries		24 hours after tracheal intubation	No
Secondary	incidence of hoarseness		24, 48, and 72 hours after tracheal intubation	No
Secondary	incidence of soar throat		24, 48, and 72 hours after tracheal intubation	No