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

Anaesthesia Clinical Trial

Official title:

Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041352
• Other study ID #: Laryngeal mask or endotracheal
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: January 17, 2012
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effects
• Anaesthesia

Intervention

Device:
• laryngeal mask
LMA Proseal
• endotracheal tube
Unomedical endotracheal tube

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of anaesthesia		2 years	No
Secondary	adverse effects using the 2 methods		2 years	Yes