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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00402870
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : December 4, 2007
Sponsor:
Information provided by:
Medical University Innsbruck

Tracking Information
First Submitted Date  ICMJE November 20, 2006
First Posted Date  ICMJE November 22, 2006
Last Update Posted Date December 4, 2007
Study Start Date  ICMJE August 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
Postoperative analgesia [ Time Frame: 24 hrs ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
Postoperative analgesia
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
Official Title  ICMJE Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intubation
Intervention  ICMJE
  • Device: ProSeal LMA
    ProSeal LMA vs Tracheal Tube
  • Device: ProSeal LMA, Tracheal Tube
    ProSeal LMA vs Tracheal Tube
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 3, 2007)
100
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00402870
Other Study ID Numbers  ICMJE 2006-95
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University Innsbruck, Christian Keller, MD, M.Sc.
Study Sponsor  ICMJE Medical University Innsbruck
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Keller, MD, M.Sc. Dept of Anesthesia, Medical University Innsbruck
PRS Account Medical University Innsbruck
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP