Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000930987
Ethics application status
Approved
Date submitted
30/08/2011
Date registered
30/08/2011
Date last updated
9/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the ProSeal laryngeal mask airway with standard endotracheal tube in gynaecological laparoscopy
Scientific title
A single blinded, randomised controlled trial in women undergoing intermediate-duration gynaecological laparoscopy comparing the ProSeal (TM) laryngeal mask airway and the endotracheal tube.
Secondary ID [1] 262960 0
Nil
Universal Trial Number (UTN)
U1111-1124-1766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain 270684 0
Condition category
Condition code
Anaesthesiology 270858 270858 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 269299 0
Treatment: Devices
Comparator / control treatment
Standard Mallinckrodt endo-tracheal tube.
Following the induction of general anaesthesia, the patient will have a laryngoscopy performed, and then a standard size 7mm endotracheal tube will be inserted into the trachea. The cuff will be inflated and the pressure checked at 20 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.
Control group
Active

Outcomes
Primary outcome [1] 279535 0
Post-operative pain
A verbal analogue scale (VAS) pain score will be recorded.
A quantitative assessment will be made of the consumption of analgesics prescribed on an as needed basis (prn) - morphine in the first two hours and oxycodone thereafter.
Timepoint [1] 279535 0
2 hours and 24 hours post-operatively
Primary outcome [2] 279536 0
Post-operative nausea and vomiting
The patient will be asked if they have suffered from nausea (yes/no) or vomiting (yes/no). Also, whether they have required any antiemetic medications to be administered and whether they have been effective.
Timepoint [2] 279536 0
2 hours and 24 hours post-operatively
Secondary outcome [1] 287860 0
Post-operative sore throat
Patients will be asked whether they have a sore throat (yes/no)
Timepoint [1] 287860 0
2 hours and 24 hours post-operatively
Secondary outcome [2] 287861 0
Post-operative hoarse voice
Patients will be asked if they have a hoarse voice (yes/no)
Timepoint [2] 287861 0
2 hours and 24 hours post-operatively

Eligibility
Key inclusion criteria
Adult female patients undergoing relaxant general anaesthesia for intermediate-duration gynaecological laparoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Investigator meets patient and provides written information, obtains written consent.

Study pack is provided to treating anaesthetist, including allocation in a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence, block randomised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2009
Actual
13/10/2009
Date of last participant enrolment
Anticipated
Actual
7/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269761 0
Hospital
Name [1] 269761 0
Royal Women's Hospital
Country [1] 269761 0
Australia
Primary sponsor type
Individual
Name
Dr James Griffiths
Address
Department of Anaesthesia
Royal Women's Hospital
Flemington Rd
Parkville, Vic. 3052
Country
Australia
Secondary sponsor category [1] 268797 0
Individual
Name [1] 268797 0
A/Prof Daryl Williams
Address [1] 268797 0
Department of Anaesthesia
Royal Melbourne Hospital
Parkville, Vic 3052
Country [1] 268797 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271721 0
Ethics and Research Committees, Royal Women's Hospital
Ethics committee address [1] 271721 0
Royal Women's Hospital
Flemington Rd
Parkville, Vic 3052
Ethics committee country [1] 271721 0
Australia
Date submitted for ethics approval [1] 271721 0
Approval date [1] 271721 0
01/10/2009
Ethics approval number [1] 271721 0
09/37

Summary
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.
Trial website
Trial related presentations / publications
Griffiths JD, Nguyen M, Lau H, Grant S, Williams D. A Prospective Randomised Comparison of the LMA-ProSeal (Trademark) versus endotracheal tube on the severity of post-operative pain following gynaecological laparoscopy. Anaesth Intensive Care 2013; 41: 46-50
Public notes

Contacts
Principal investigator
Name 33094 0
Dr James Griffiths
Address 33094 0
Royal Womens Hospital
20 Flemington Rd
Parkville Vic 3052
Country 33094 0
Australia
Phone 33094 0
+61383452000
Fax 33094 0
Email 33094 0
[email protected]
Contact person for public queries
Name 16341 0
Dr Dr James Griffiths
Address 16341 0
Department of Anaesthesia
Royal Women's Hospital
Flemington Rd
PARKVILLE Vic 3052
Country 16341 0
Australia
Phone 16341 0
+61383452000
Fax 16341 0
+61383452379
Email 16341 0
[email protected]
Contact person for scientific queries
Name 7269 0
Dr Dr James Griffiths
Address 7269 0
Department of Anaesthesia
Royal Women's Hospital
Flemington Rd
PARKVILLE Vic 3052
Country 7269 0
Australia
Phone 7269 0
+61383452000
Fax 7269 0
+61383452379
Email 7269 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.