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

Not Applicable

Completed

• Conditions: Adverse Effects; Anaesthesia
• Interventions: Device: endotracheal tube; Device: laryngeal mask

• Registration Number: NCT01041352
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-30
• Study First Submitted QC: 2009-12-30
• Study First Posted: 2009-12-31
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal group	endotracheal tube	airway management: endotracheal tube
laryngeal mask group	laryngeal mask	airway management: laryngeal mask

Primary Outcome Measures

Name	Time	Method
time of anaesthesia	2 years

Secondary Outcome Measures

Name	Time	Method
adverse effects using the 2 methods	2 years

Trial Locations

Locations (1)

Glostrup University Hospital; 🇩🇰 Glostrup, Denmark