Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000394640
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
18/04/2023
Date last updated
4/08/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Sugammadex, neostigmine and postoperative pulmonary complications (SNaPP): a randomised controlled trial
Scientific title
The SNaPP Study: A multi-centre, patient- and observer-blinded randomised controlled trial of sugammadex or neostigmine to reverse neuromuscular blockade in adult patients having abdominal and thoracic surgery under general anaesthesia
Secondary ID [1] 309045 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The SNaPP Study
Linked study record
This record is a follow-up study of ACTRN12620001313921.

Health condition
Health condition(s) or problem(s) studied:
Pulmonary atelectasis 329096 0
Pneumonia 329097 0
Acute respiratory distress syndrome 329098 0
Pulmonary aspiration 329099 0
Condition category
Condition code
Anaesthesiology 326072 326072 0 0
Anaesthetics
Surgery 326073 326073 0 0
Other surgery
Respiratory 326074 326074 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sugammadex as a single intravenous dose at the end of surgery with dose personalised by quantitative neuromuscular monitoring. Quantitative neuromuscular monitoring is recommended by the Australian and New Zealand College of Anaesthetists. It is applied at induction of anaesthesia and is removed after reversal of neuromuscular blockade at the end of surgery. Quantitative neuromuscular monitoring results, reversal drug name and dose will be recorded in the hospital medical record. Adherance to the intervention will be monitored via audit of the hospital medical record.
Intervention code [1] 325487 0
Prevention
Comparator / control treatment
Neostigmine as a single intravenous dose at the end of surgery with dose personalised by quantitative neuromuscular monitoring. Quantitative neuromuscular monitoring is recommended by the Australian and New Zealand College of Anaesthetists. It is applied at induction of anaesthesia and is removed after reversal of neuromuscular blockade at the end of surgery. Quantitative neuromuscular monitoring results, reversal drug name and dose will be recorded in the hospital medical record. Adherance to the intervention will be monitored via audit of the hospital medical record.
Control group
Active

Outcomes
Primary outcome [1] 333937 0
Incidence of a composite of death from all causes and new pulmonary complications as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [1] 333937 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [1] 418784 0
Incidence of death from all causes as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [1] 418784 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [2] 418785 0
Incidence of pulmonary atelectasis as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [2] 418785 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [3] 418786 0
Incidence of pneumonia as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [3] 418786 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [4] 418787 0
Incidence of acute respiratory distress syndrome as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [4] 418787 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [5] 418788 0
Incidence of pulmonary aspiration as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [5] 418788 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [6] 418789 0
Incidence of postoperative nausea and vomiting as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [6] 418789 0
From admission to post anaesthesia care unit until postoperative day 1
Secondary outcome [7] 418790 0
Incidence of unplanned intensive care unit/high dependency unit admission as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [7] 418790 0
From admission to post anaesthesia care unit until hospital discharge
Secondary outcome [8] 418791 0
Days alive and at home as assessed by trial coordinators during medical record review and postoperative phone call
Timepoint [8] 418791 0
From induction of anaesthesia until 30 days postoperatively
Secondary outcome [9] 418792 0
Change in health-related quality of life score measured by the EuroOoL - 5 dimension - 5 level score
Timepoint [9] 418792 0
Between two measurements (baseline and 3 months postoperatively)

Eligibility
Key inclusion criteria
1. Plan for elective or expedited intraabdominal, retroperitoneal, pelvic and non-cardiac intrathoracic surgery
2. Plan for relaxant general anaesthesia with an endotracheal tube
3. Surgery expected to last greater than or equal to 2 hours
4.Expected hospital stay of greater than or equal to 1 postoperative night
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide written informed consent (e.g., language barrier, intellectual disability, cognitive deficit, urgent surgery)
2. Plan for skin incision and/or vascular access at or below the inguinal ligament without an abdominal or thoracic skin incision
3. Plan for intraoperative administration of neuromuscular blocking drug other than rocuronium and vecuronium
4. Plan to reverse neuromuscular blockade during surgery
5. Plan to allow spontaneous complete recovery from neuromuscular blockade during surgery
6. Contraindication to sugammadex or neostigmine
7. Plan for elective postoperative invasive ventilation
8. Previously randomised to the trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3500
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25277 0
New Zealand
State/province [1] 25277 0
Country [2] 25278 0
Hong Kong
State/province [2] 25278 0

Funding & Sponsors
Funding source category [1] 313248 0
Government body
Name [1] 313248 0
Medical Research Future Fund
Country [1] 313248 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne,
Parkville, VIC, 3010
Country
Australia
Secondary sponsor category [1] 314980 0
None
Name [1] 314980 0
Address [1] 314980 0
Country [1] 314980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312480 0
Royal Melbourne Hospital
Ethics committee address [1] 312480 0
300 Grattan St
Parkville, VIC, 3050
Ethics committee country [1] 312480 0
Australia
Date submitted for ethics approval [1] 312480 0
Approval date [1] 312480 0
27/03/2023
Ethics approval number [1] 312480 0
HREC/93017/MH-2023

Summary
Brief summary
During general anaesthesia muscle relaxant drugs are administered to make airway management and surgery easier. Muscle relaxants are usually reversed with neostigmine at the end of the operation. A newer drug, sugammadex, reverses muscle relaxants more rapidly than neostigmine, but is not clear whether sugammadex results in fewer postoperative complications than neostigmine. We are conducting a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124810 0
Prof Kate Leslie
Address 124810 0
Department of Anaesthesia and Pain Management,
Royal Melbourne Hospital,
300 Grattan St,
Parkville, VIC, 3050
Country 124810 0
Australia
Phone 124810 0
+61 3 93427540
Fax 124810 0
Email 124810 0
kate.leslie@mh.org.au
Contact person for public queries
Name 124811 0
Prof Kate Leslie
Address 124811 0
Department of Anaesthesia and Pain Management,
Royal Melbourne Hospital,
300 Grattan St,
Parkville, VIC, 3050
Country 124811 0
Australia
Phone 124811 0
+61 3 93427540
Fax 124811 0
Email 124811 0
kate.leslie@mh.org.au
Contact person for scientific queries
Name 124812 0
Prof Kate Leslie
Address 124812 0
Department of Anaesthesia and Pain Management,
Royal Melbourne Hospital,
300 Grattan St,
Parkville, VIC, 3050
Country 124812 0
Australia
Phone 124812 0
+61 3 93427540
Fax 124812 0
Email 124812 0
kate.leslie@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data except for identifying variables
When will data be available (start and end dates)?
One year after the publication of the main study results with no end date
Available to whom?
Access will be decided on a case-by-case basis by the trial steering committee.
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
From the principal investigator (by email kate.leslie@mh.org.au), subject to approvals as determined by the trial steering committee


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.