Comparing the ProSeal laryngeal mask airway with standard endotracheal tube in gynaecological laparoscopy

A single blinded, randomised controlled trial in women undergoing intermediate-duration gynaecological laparoscopy comparing the ProSeal (TM) laryngeal mask airway and the endotracheal tube.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000930987

Enrollment

120

Registered

2011-08-30

Start date

2009-10-13

Completion date

2011-09-07

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The trial aims to assess whether in women undergoing simple gynaecological laparoscopy, the Proseal (TM) airway device reduces post-operative pain and/or nausea and vomiting. We will also assess whether the device reduces sore throat or hoarse voice.

Interventions

ProSeal (TM) laryngeal mask airway. The airway device will be inserted once the patient is anaesthetised, using a "railroad" technique over a bougie placed in the oesophagus by laryngoscopy. The cuff will be inflated and the pressure adjusted to 60 cmH20 using a hand pressure gauge. The airway device will remain in place for the duration of the surgical procedure. The device will be removed from the airway immediately prior to emergence from general anaesthesia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult female patients undergoing relaxant general anaesthesia for intermediate-duration gynaecological laparoscopy

Exclusion criteria

Anticipated surgical duration less than 30 minutes or greater than 120 minutes Contraindications to the use of a LMA in laparoscopic surgery - obesity, symptoms of gastroesophageal reflux, known or anticipated difficult airway Contraindications to any study drug (including morphine and parecoxib)

Outcome results