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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014