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

NCT ID: NCT01896245

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Other Specified Injuries of Vocal Cord, Sequela

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sevoflurane 1,0

sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC

Group Type ACTIVE_COMPARATOR

sevoflurane 1,0

Intervention Type DRUG

anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation

sevoflurane 1,2

sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC

Group Type ACTIVE_COMPARATOR

sevoflurane 1,2

Intervention Type DRUG

anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation

sevoflurane 1,4

sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC

Group Type ACTIVE_COMPARATOR

sevoflurane 1,4

Intervention Type DRUG

anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation

Interventions

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sevoflurane 1,0

anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation

Intervention Type DRUG

sevoflurane 1,2

anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation

Intervention Type DRUG

sevoflurane 1,4

anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation

Intervention Type DRUG

Other Intervention Names

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sevo 2,0 % sevo 2,5 % sevo 3,0 %

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Thomas Mencke

Clinical Associate Professor Dr Thomas Mencke

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Mencke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany

Locations

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Department of Anesthesia and Intensive Care Medicine, University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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Ovari A, Bicker I, Machmueller S, Schuldt T, Sauer M, Soltesz S, Noeldge-Schomburg G, Mlynski R, Mencke T. Sevoflurane at 1.0 MAC together with remifentanil and propofol produces clinically acceptable intubation conditions at the vocal cords: A prospective randomized study. J Int Med Res. 2017 Jun;45(3):1098-1108. doi: 10.1177/0300060517701355. Epub 2017 Apr 28.

Reference Type DERIVED
PMID: 28449630 (View on PubMed)

Other Identifiers

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A 2013-0039

Identifier Type: -

Identifier Source: org_study_id

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