Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

NCT01591031 | Completed

• 1 other identifier: A 2011 124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia induction with sevoflurane is not associated with an increased incidence or severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.

Conditions

Laryngeal Injuries

Keywords

laryngeal injuries; vocal cord injuries; hoarseness; sore throat

Outcome Measures

Primary Outcomes (1)

• incidence of vocal cord injuries

  24 h after tracheal intubation

Secondary Outcomes (2)

• incidence of hoarseness

  24h, 48 h, and 72 h after tracheal intubation

• incidence of soar throat

  24h, 48h, and 72 h after tracheal intubation

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

anesthesia induction with propofol, remifentanil and sevoflurane

Drug: Sevoflurane

rocuronium

ACTIVE COMPARATOR

anesthesia induction with propofol, remifentanil and rocuronium

Drug: Rocuronium

Interventions

Sevoflurane DRUG

anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation

sevoflurane

Rocuronium DRUG

anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation

rocuronium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ear-nose-throat surgery
• orotracheal intubation for surgery of the ear

You may not qualify if:

• obesity
• allergy against the study drugs
• patients with a known or suspected difficult airway (Mallampati score 3 or 4 and a mouth opening \< 3.5 cm).
• all patients were examined by stroboscopy one day before surgery and were excluded from the study when preexisting pathologies of the vocal cords were found

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related Publications (1)

• Mencke T, Jacobs RM, Machmueller S, Sauer M, Heidecke C, Kallert A, Pau HW, Noeldge-Schomburg G, Ovari A. Intubating conditions and side effects of propofol, remifentanil and sevoflurane compared with propofol, remifentanil and rocuronium: a randomised, prospective, clinical trial. BMC Anesthesiol. 2014 May 22;14:39. doi: 10.1186/1471-2253-14-39. eCollection 2014.

  PMID: 24860256 DERIVED

MeSH Terms

Conditions

Hoarseness; Pharyngitis

Interventions

Sevoflurane; Rocuronium

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invastigator, Clinical Associate Professor, Dr. Thomas Mencke

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 3, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

DE (1)