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

NCT ID: NCT01616966

Last Updated: 2012-07-03

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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Vocal Cord; Injury, Superficial

Keywords

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hoarseness sore throat vocal cord injuries

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

Anesthesia was maintained with sevoflurane during surgery.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Maintenance of anesthesia with sevoflurane 1.0 Vol%

Anesthesia with propofol

Anesthesia was maintained with propofol during surgery.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

Maintenance of anesthesia with propofol

Interventions

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Sevoflurane

Maintenance of anesthesia with sevoflurane 1.0 Vol%

Intervention Type DRUG

propofol

Maintenance of anesthesia with propofol

Intervention Type DRUG

Other Intervention Names

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remifentanil remifentanil

Eligibility Criteria

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Inclusion Criteria

* orotracheal intubation
* surgery of the ear
* written consent
* ASA I-III

Exclusion Criteria

* preexisting pathologies of the vocal cords
* obesity
* difficult airway
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

Thomas Mencke

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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A 2010 29

Identifier Type: -

Identifier Source: org_study_id