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Completed

NCT Number: NCT01041352

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glostrup University Hospital

Glostrup Municipality, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal Mask

Device

LMA Proseal

Endotracheal tube

Device

Unomedical endotracheal tube

Primary outcomes

  1. time of anaesthesia

    Time frame: 2 years

Secondary outcomes

  1. adverse effects using the 2 methods

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 31, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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