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
ACTRN12611000789965
Ethics application status
Approved
Date submitted
26/07/2011
Date registered
28/07/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of two different drugs on post-operative well-being, nausea and vomiting in patients undergoing laparoscopic gynaecological surgery
Scientific title
Neostigmine and glycopyrrolate versus sugammadex in post-operative nausea and vomiting (PONV) following reversal of neuromuscular block in patients undergoing laparoscopic gynaecological surgery: a randomised controlled trial (RCT).
Secondary ID [1] 262686 0
Nil
Universal Trial Number (UTN)
Trial acronym
WINGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reversal of pharmacological neuromuscular block following surgery. 268390 0
Condition category
Condition code
Anaesthesiology 268531 268531 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of an intravenous bolus of sugammadex 2mg/kg actual body weight, following surgery and prior to emergence from anaesthesia, in patients where rocuronium has been used, and where at least two twitches of a 'train-of-four' nerve stimulation test has been demonstrated.
Intervention code [1] 267033 0
Treatment: Drugs
Comparator / control treatment
Administration of an intravenous bolus of neostigmine 50mcg/kg actual body weight (to a maximum of 5mg) with glycopyrrolate 10mcg/kg (to a maximum of 800mcg), following surgery and prior to emergence from anaesthesia, in patients where rocuronium has been used, and where at least two twitches of a 'train-of-four' nerve stimulation test has been demonstrated.
Control group
Active

Outcomes
Primary outcome [1] 269273 0
Cumulative incidence and severity of post-operative nausea and vomiting (PONV), as determined by numerical rating scores for nausea and the ?clinically significant PONV? score
Timepoint [1] 269273 0
6 hours post-operatively
Secondary outcome [1] 279264 0
Time to first dose of rescue anti-emetic
Timepoint [1] 279264 0
Within first 24 hours post-operatively
Secondary outcome [2] 279271 0
Pain intensity at arousal post-operatively, self-assessed using numerical rating score
Timepoint [2] 279271 0
2, 6 and 24 hours post-operatively
Secondary outcome [3] 279272 0
Patient symptoms of normal muscle strength, visual acuity and dry mouth on arousal, self-assessed using numerical rating score
Timepoint [3] 279272 0
2, 6 and 24 hours post-operatively
Secondary outcome [4] 279273 0
Patient-rated return of bowel function, by use of a questionnaire
Timepoint [4] 279273 0
24 hours post-operatively
Secondary outcome [5] 279274 0
Patient-rated global return of usual mobility, by use of a subjective scoring system
Timepoint [5] 279274 0
2, 6 and 24 hours post-operatively
Secondary outcome [6] 279275 0
Patient-rated return to normal function following anaesthesia, using a validated quality of recovery scoring system
Timepoint [6] 279275 0
24 hours post-operatively
Secondary outcome [7] 279276 0
Time to readiness for discharge for day-case procedures, as determined by recovery room nursing staff using existing departmental criteria
Timepoint [7] 279276 0
Variable, up to 24 hours post-operatively
Secondary outcome [8] 279308 0
Cumulative incidence and severity of post-operative nausea and vomiting (PONV), as determined by numerical rating scores for nausea and the ?clinically significant PONV? score
Timepoint [8] 279308 0
2 and 24 hours post-operatively

Eligibility
Key inclusion criteria
ASA I – III physical status;
Elective or non-elective laparoscopic gynaecological surgery;
General anaesthesia with intravenous induction of anaesthesia and neuromuscular block with rocuronium;
Ability to communicate in English.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Anaphylaxis or hypersensitivity to any of the study drugs;
Anaesthetist preference to avoid a long acting muscle relaxant (for example, known or anticipated difficult airway);
Preoperative or perioperative conversion to open abdominal surgery;
Preoperative nausea and/or vomiting within 48 hours of surgery;
Neuromuscular disease;
Hepatic or renal dysfunction;
Personal or family history of malignant hyperpyrexia;
Long QT syndrome;
Pregnancy or breastfeeding;
Unsuitable for follow-up by phone at 24 hours (if day stay procedure).

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)
Patients are screened for eligibility by a member of the clinical research team on wards or in pre-operative clinic. Informed consent is sought and the patient enrolled.
The study drugs are prepared by an independent operator and are indistinguishable.
Study group allocation using serially numbered secure envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Normal clinical practice changed over study period, limiting suitability of techniques for nature of surgery.
Date of first participant enrolment
Anticipated
1/08/2011
Actual
20/10/2011
Date of last participant enrolment
Anticipated
Actual
27/10/2016
Date of last data collection
Anticipated
Actual
27/11/2016
Sample size
Target
360
Accrual to date
Final
307
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2400 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 8048 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 267505 0
Hospital
Name [1] 267505 0
King Edward Memorial Hospital
Country [1] 267505 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
374 Bagot Rd, Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 266548 0
None
Name [1] 266548 0
Address [1] 266548 0
Country [1] 266548 0
Other collaborator category [1] 252119 0
University
Name [1] 252119 0
University of Western Australia
Address [1] 252119 0
c/o Prof Michael Paech, Department of Anaesthesia, King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA 6008
Country [1] 252119 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269470 0
Women and Newborn Health Service Research Ethics Committee
Ethics committee address [1] 269470 0
Room 134
Level 1, Children's Clinical Research Facility
Princess Margaret Hospital
Cnr Hamilton Street & Roberts Road
Subiaco
WA 6008
Ethics committee country [1] 269470 0
Australia
Date submitted for ethics approval [1] 269470 0
Approval date [1] 269470 0
19/07/2011
Ethics approval number [1] 269470 0
1920/EW

Summary
Brief summary
To compare patient outcome, the primary endpoint being the incidence of post-operative nausea and vomiting (PONV), associated with the use of either neostigmine and glycopyrrolate or sugammadex for the routine reversal of neuromuscular block following laparoscopic gynaecological surgery.

Secondary outcomes to be assessed include readiness to discharge, return of normal bowel function, patient recovery and well-being.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32912 0
Dr Richard Kaye
Address 32912 0
c/o Prof Michael Paech, Department of Anaesthesia, King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA 6008
Country 32912 0
Australia
Phone 32912 0
+61 8 93402222
Fax 32912 0
Email 32912 0
[email protected]
Contact person for public queries
Name 16159 0
Prof Prof Michael Paech
Address 16159 0
Department of Anaesthesia
King Edward Memorial Hospital
Bagot Road
Subiaco
WA 6008
Country 16159 0
Australia
Phone 16159 0
+61 8 9340 2222
Fax 16159 0
+61 8 9340 2227
Email 16159 0
[email protected]
Contact person for scientific queries
Name 7087 0
Prof Prof Michael Paech
Address 7087 0
Department of Anaesthesia
King Edward Memorial Hospital
Bagot Road
Subiaco
WA 6008
Country 7087 0
Australia
Phone 7087 0
+61 8 9340 2222
Fax 7087 0
+61 8 9340 2227
Email 7087 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.