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

This study has been completed.
Information provided by (Responsible Party):
Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen Identifier:
First received: December 30, 2009
Last updated: January 17, 2012
Last verified: January 2012

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.

Condition Intervention
Adverse Effects
Device: laryngeal mask
Device: endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.

Resource links provided by NLM:

Further study details as provided by Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • time of anaesthesia [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • adverse effects using the 2 methods [ Time Frame: 2 years ]

Enrollment: 136
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endotracheal group
airway management: endotracheal tube
Device: endotracheal tube
Unomedical endotracheal tube
Active Comparator: laryngeal mask group
airway management: laryngeal mask
Device: laryngeal mask
LMA Proseal


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion Criteria:

  • Body mass index >35
  • Expected time of surgery > 2 hours
  Contacts and Locations
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Please refer to this study by its identifier: NCT01041352

Glostrup University Hospital
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Study Chair: Karsten S Olsen, MD, DMSc
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karsten Skovgaard Olsen, Consultant, DMSC, Glostrup University Hospital, Copenhagen Identifier: NCT01041352     History of Changes
Other Study ID Numbers: Laryngeal mask or endotracheal
Study First Received: December 30, 2009
Last Updated: January 17, 2012

Keywords provided by Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen:
laryngeal mask
prone position processed this record on May 25, 2017