Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol

Vocal Cord; Injury, Superficial Clinical Trial

Official title:

Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616966
• Other study ID #: A 2010 29
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 29, 2012
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• 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

Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

Description:

Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• orotracheal intubation

• surgery of the ear

• written consent

• ASA I-III

Exclusion Criteria:

• preexisting pathologies of the vocal cords

• obesity

• difficult airway

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

• Vocal Cord; Injury, Superficial

Intervention

Drug:
• Sevoflurane
Maintenance of anesthesia with sevoflurane 1.0 Vol%
• propofol
Maintenance of anesthesia with propofol

Locations

Country	Name	City	State
Germany	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	assessed by stroboscopy	24h after surgery	No
Secondary	incidence of hoarseness		24h after surgery	No