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Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402870
First Posted: November 22, 2006
Last Update Posted: December 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University Innsbruck
November 20, 2006
November 22, 2006
December 4, 2007
August 2007
Not Provided
Postoperative analgesia [ Time Frame: 24 hrs ]
Postoperative analgesia
Complete list of historical versions of study NCT00402870 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Intubation
  • Device: ProSeal LMA
    ProSeal LMA vs Tracheal Tube
  • Device: ProSeal LMA, Tracheal Tube
    ProSeal LMA vs Tracheal Tube
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2007
Not Provided

Inclusion Criteria:

  • Female
  • ASA I-II
  • Age 18-75
  • Elective laparoscopic surgery

Exclusion Criteria:

  • Known or predicted difficult airway
  • Oropharyngeal pathology
  • Mouth opening < 3.0 cm
  • A body mass index > 35 kg m-2
  • Increased risk of aspiration
  • Inability to communicate or understand the visual analogue scale
  • Analgesics within 24 hours of surgery
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00402870
2006-95
Not Provided
Not Provided
Not Provided
Medical University Innsbruck, Christian Keller, MD, M.Sc.
Medical University Innsbruck
Not Provided
Principal Investigator: Christian Keller, MD, M.Sc. Dept of Anesthesia, Medical University Innsbruck
Medical University Innsbruck
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP