Intubation Clinical Trial
Official title:
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
Verified date | December 2007 |
Source | Medical University Innsbruck |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Dept of Anesthesia | Innsbruck |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative analgesia | 24 hrs | No |
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