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.

Status Completed

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.

Clinical Trial Description

n/a

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

• NCT number: NCT01041352
• Study type: Interventional
• Source: Glostrup University Hospital, Copenhagen
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Completion date: September 2011