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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041352
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen

Brief Summary:

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 or disease Intervention/treatment Phase
Anaesthesia Adverse Effects Device: laryngeal mask Device: endotracheal tube Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041352

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

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
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen:
laryngeal mask
prone position