Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position

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

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.

Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.

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Detailed Description

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Conditions

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Anaesthesia Adverse Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endotracheal group

airway management: endotracheal tube

Group Type ACTIVE_COMPARATOR

endotracheal tube

Intervention Type DEVICE

Unomedical endotracheal tube

laryngeal mask group

airway management: laryngeal mask

Group Type ACTIVE_COMPARATOR

laryngeal mask

Intervention Type DEVICE

LMA Proseal

Interventions

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laryngeal mask

LMA Proseal

Intervention Type DEVICE

endotracheal tube

Unomedical endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for backsurgery of an espected duration less than 2 hours,
* Age 18-70 years,
* ASA (american society of anaaesthesiology) class 1-2,
* Normal airways