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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402870

Enrollment

100

Registered

2006-11-22

Start date

2007-08-31

Completion date

2007-09-30

Last updated

2007-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation

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.

Interventions

DEVICEProSeal LMA

ProSeal LMA vs Tracheal Tube

DEVICEProSeal LMA, Tracheal Tube

ProSeal LMA vs Tracheal Tube

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Postoperative analgesia	24 hrs

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026