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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
  Purpose
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.

Condition Intervention
Intubation Device: ProSeal LMA Device: ProSeal LMA, Tracheal Tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Postoperative analgesia [ Time Frame: 24 hrs ]

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: September 2007
Intervention Details:
    Device: ProSeal LMA
    ProSeal LMA vs Tracheal Tube
    Device: ProSeal LMA, Tracheal Tube
    ProSeal LMA vs Tracheal Tube
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402870


Locations
Austria
Dept of Anesthesia
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Christian Keller, MD, M.Sc. Dept of Anesthesia, Medical University Innsbruck
  More Information

Responsible Party: Medical University Innsbruck, Christian Keller, MD, M.Sc.
ClinicalTrials.gov Identifier: NCT00402870     History of Changes
Other Study ID Numbers: 2006-95
First Submitted: November 20, 2006
First Posted: November 22, 2006
Last Update Posted: December 4, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs