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

December 3, 2007 updated by: Medical University Innsbruck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Dept of anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative analgesia
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Christian Keller, MD, M.Sc., Dept of Anesthesia, Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 2006-95

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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