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

NCT ID: NCT00402870

Last Updated: 2007-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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ProSeal LMA

ProSeal LMA vs Tracheal Tube

Intervention Type DEVICE

ProSeal LMA, Tracheal Tube

ProSeal LMA vs Tracheal Tube

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Christian Keller, MD, M.Sc.

Principal Investigators

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Christian Keller, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesia, Medical University Innsbruck

Locations

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Dept of Anesthesia

Innsbruck, Innsbruck, Austria

Site Status

Countries

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Austria

Other Identifiers

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2006-95

Identifier Type: -

Identifier Source: org_study_id