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

Not Applicable

Completed

• Conditions: Intubation

• Registration Number: NCT00402870
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Study Start: 2007-08
• Study Completion: 2007-09
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia	24 hrs

Trial Locations

Locations (1)

Dept of Anesthesia; 🇦🇹 Innsbruck, Austria