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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01041352
Enrollment
136
Registered
2009-12-31
Start date
2009-10-31
Completion date
2011-09-30
Last updated
2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effects, Anaesthesia

Keywords

anaesthesia, laryngeal mask, prone position

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.

Interventions

LMA Proseal

DEVICEendotracheal tube

Unomedical endotracheal tube

Sponsors

Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
time of anaesthesia2 years

Secondary

MeasureTime frame
adverse effects using the 2 methods2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026