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

Not Applicable

Completed

• Conditions: Other Specified Injuries of Vocal Cord, Sequela
• Interventions: Drug: sevoflurane 1,4; Drug: sevoflurane 1,0; Drug: sevoflurane 1,2

• Registration Number: NCT01896245
• Lead Sponsor: University of Rostock

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-11
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane 1,4	sevoflurane 1,4	sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
sevoflurane 1,0	sevoflurane 1,0	sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
sevoflurane 1,2	sevoflurane 1,2	sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC

Primary Outcome Measures

Name	Time	Method
incidence of vocal cord injuries	24 hours after tracheal intubation

Secondary Outcome Measures

Name	Time	Method
incidence of soar throat	24, 48, and 72 hours after tracheal intubation
incidence of hoarseness	24, 48, and 72 hours after tracheal intubation

Trial Locations

Locations (1)

Department of Anesthesia and Intensive Care Medicine, University of Rostock; 🇩🇪 Rostock, Mecklenburg/Vorpommern, Germany