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

Not Applicable

Completed

• Conditions: Vocal Cord; Injury, Superficial
• Interventions: Drug: Sevoflurane; Drug: propofol

• Registration Number: NCT01616966
• Lead Sponsor: University of Rostock

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	Anesthesia was maintained with sevoflurane during surgery.
Anesthesia with propofol	propofol	Anesthesia was maintained with propofol during surgery.

Primary Outcome Measures

Name	Time	Method
incidence of vocal cord injuries	24h after surgery	assessed by stroboscopy

Secondary Outcome Measures

Name	Time	Method
incidence of hoarseness	24h after surgery

Trial Locations

Locations (1)

University of Rostock; 🇩🇪 Rostock, Mecklenburg/Vorpommern, Germany