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

This study has been completed.

Sponsored by:	Medical University Innsbruck
Information provided by:	Medical University Innsbruck
ClinicalTrials.gov Identifier:	NCT00402870

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
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:

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

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

ClinicalTrials.gov processed this record on January 14, 2009