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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karsten Skovgaard Olsen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01041352
First received: December 30, 2009
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Anaesthesia
Adverse Effects
 Device: laryngeal mask
Device: endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

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

Primary Outcome Measures:
  • time of anaesthesia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse effects using the 2 methods [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041352

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

No publications provided

Responsible Party: Karsten Skovgaard Olsen, Consultant, DMSC, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01041352     History of Changes
Other Study ID Numbers: Laryngeal mask or endotracheal
Study First Received: December 30, 2009
Last Updated: January 17, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Glostrup University Hospital, Copenhagen:
anaesthesia
laryngeal mask
prone position

ClinicalTrials.gov processed this record on June 18, 2013