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OpenTrials
Completed

NCT Number: NCT00402870

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

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.

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Key information

Conditions

Intubation

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Anesthesia

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proseal LMA

Device

ProSeal LMA vs Tracheal Tube

ProSeal LMA, Tracheal Tube

Device

ProSeal LMA vs Tracheal Tube

Primary outcomes

  1. Postoperative analgesia

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Dec 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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