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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:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00402870
First received: November 20, 2006
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical University Innsbruck, Christian Keller, MD, M.Sc.
ClinicalTrials.gov Identifier: NCT00402870     History of Changes
Other Study ID Numbers: 2006-95
Study First Received: November 20, 2006
Last Updated: December 3, 2007
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013