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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402870
Other study ID # 2006-95
Secondary ID
Status Completed
Phase N/A
First received November 20, 2006
Last updated December 3, 2007
Start date August 2007
Est. completion date September 2007

Study information

Verified date December 2007
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
ProSeal LMA
ProSeal LMA vs Tracheal Tube
ProSeal LMA, Tracheal Tube
ProSeal LMA vs Tracheal Tube

Locations

Country Name City State
Austria Dept of Anesthesia Innsbruck

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative analgesia 24 hrs No
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