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Trial registered on ANZCTR


Registration number
ACTRN12620001313921
Ethics application status
Approved
Date submitted
8/10/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sugammadex, neostigmine and postoperative pulmonary complications (SNaPP): a feasibility and pilot trial
Scientific title
The SNaPP Pilot Study: A feasibility and pilot study for 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] 302392 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The SNaPP Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary atelectasis 319179 0
Pneumonia 319659 0
Acute respiratory distress syndrome 319660 0
Pulmonary aspiration 319661 0
Respiratory 319997 0
Condition category
Condition code
Anaesthesiology 317149 317149 0 0
Anaesthetics
Surgery 317588 317588 0 0
Other surgery
Respiratory 317925 317925 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 will be recorded in the case report form. Administration of neostigmine instead of sugammadex will be at the discretion of the anaesthetist based on patient safety considerations.
Intervention code [1] 318672 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 will be recorded in the case report form. Administration of sugammadex instead of neostigmine will be at the discretion of the anaesthetist based on patient safety considerations.
Control group
Active

Outcomes
Primary outcome [1] 325222 0
Rate of recruitment of eligible patients who were approached for consent to participate, as recorded in screening log
Timepoint [1] 325222 0
At the time of attempted recruitment between booking for surgery and arrival in the operating room
Secondary outcome [1] 387245 0
Incidence of administration of randomised intervention without crossover to alternative intervention (excluding any rescue reversal administered), as recorded on case report form
Timepoint [1] 387245 0
At the time of administration of reversal agent at the end of surgery
Secondary outcome [2] 387246 0
Acceptability of protocol and procedures to attending anaesthetist on a 5-point Likert scale
Timepoint [2] 387246 0
On arrival in post anaesthesia care unit
Secondary outcome [3] 387247 0
Rate of contact with randomised patients, as recorded on case report form
Timepoint [3] 387247 0
3 months postoperatively
Secondary outcome [4] 387248 0
Rate of all fields in case report form complete, as recorded on case report form
Timepoint [4] 387248 0
3 months postoperatively
Secondary outcome [5] 387551 0
Time taken to screen, recruit, perform trial procedures and complete data entry (composite of time taken for each activity) as recorded in trial coordinator time log
Timepoint [5] 387551 0
3 months postoperatively
Secondary outcome [6] 387552 0
Incidence of postoperative pulmonary complications (a composite of atelectasis, pneumonia, acute respiratory distress syndrome and pulmonary aspiration) as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [6] 387552 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [7] 387553 0
Incidence of pulmonary atelectasis as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [7] 387553 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [8] 387554 0
Incidence of pneumonia as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [8] 387554 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [9] 387555 0
Incidence of acute respiratory distress syndrome as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [9] 387555 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [10] 387556 0
Incidence of pulmonary aspiration as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [10] 387556 0
From admission to post anaesthesia care unit until hospital discharge (or postoperative day 7 if still in hospital)
Secondary outcome [11] 387557 0
Incidence of postoperative nausea and vomiting as assessed by trial coordinators from patient history and medical record review during postoperative visits
Timepoint [11] 387557 0
From admission to post anaesthesia care unit until postoperative day 1
Secondary outcome [12] 387558 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 [12] 387558 0
From admission to post anaesthesia care unit until hospital discharge
Secondary outcome [13] 387559 0
Days alive and at home as assessed by trial coordinators during medical record review and postoperative phone call
Timepoint [13] 387559 0
From induction of anaesthesia until 30 days postoperatively
Secondary outcome [14] 387560 0
Change in health-related quality of life score measured by the EuroQoL - 5 dimension - 5 level score
Timepoint [14] 387560 0
Between two measurements (baseline and 3 months postoperatively)
Secondary outcome [15] 387561 0
Duration of post anaesthesia care unit stay as assessed by trial coordinators from patient history and medical record review during postoperative visit
Timepoint [15] 387561 0
Between arrival in and departure from the post anaesthesia care unit unit
Secondary outcome [16] 387562 0
Incidence of airway instrumentation as assessed by trial coordinators from patient history and medical record review during postoperative visit
Timepoint [16] 387562 0
Between arrival in and departure from the post anaesthesia care unit unit
Secondary outcome [17] 387563 0
Change in quality of recovery score measured by the Quality of Recovery-15 score
Timepoint [17] 387563 0
Between two measurements (baseline and postoperative day 1)
Secondary outcome [18] 387564 0
Change in frailty score measured by the Clinical Frailty Scale
Timepoint [18] 387564 0
Between two measurements (baseline and 3 months postoperatively)

Eligibility
Key inclusion criteria
a) Plan for elective or expedited intraabdominal, retroperitoneal, pelvic and non-cardiac intrathoracic surgery
b) Plan for relaxant general anaesthesia with an endotracheal tube
c) Surgery expected to last greater than or equal to 2 hours
d) Expected hospital stay of greater than or equal to 1 postoperative night
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Unable to provide written informed consent (e.g. language barrier, intellectual disability, cognitive deficit, urgent surgery)
b) Plan for skin incision and/or vascular access at or below the inguinal ligament without an abdominal or thoracic skin incision
c) Plan for intraoperative administration of neuromuscular blocking drug other than rocuronium and vecuronium
d) Plan to reverse neuromuscular blockade during surgery
e) Plan to allow spontaneous complete recovery from neuromuscular blockade during surgery
f) Contraindication to sugammadex or neostigmine
g) Plan for elective postoperative invasive ventilation
h) 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)
Randomisation results will be concealed in opaque envelopes to be opened by the attending anaesthetist at the end of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be computer-generated by an independent statistician using randomly permuted blocks.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17745 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 17746 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 17747 0
Northeast Health Wangaratta - Wangaratta
Recruitment postcode(s) [1] 31601 0
3050 - Parkville
Recruitment postcode(s) [2] 31602 0
3084 - Heidelberg
Recruitment postcode(s) [3] 31603 0
3677 - Wangaratta

Funding & Sponsors
Funding source category [1] 306816 0
Charities/Societies/Foundations
Name [1] 306816 0
Australian and New Zealand College of Anaesthetists
Address [1] 306816 0
620 St Kilda Rd, Melbourne, VIC, 3004
Country [1] 306816 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Office for Research
The Royal Melbourne Hospital
300 Grattan St
Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 307373 0
None
Name [1] 307373 0
Address [1] 307373 0
Country [1] 307373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306980 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 306980 0
Office for Research
Royal Melbourne Hospital
300 Grattan St
Parkville, VIC, 3050
Ethics committee country [1] 306980 0
Australia
Date submitted for ethics approval [1] 306980 0
29/09/2020
Approval date [1] 306980 0
19/10/2020
Ethics approval number [1] 306980 0

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 planning a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine. The current study is a pilot study that will determine if the larger trial is feasible. We will measure feasibility outcomes (e.g. recruitment rates) and pilot the main trial outcomes (e.g. postoperative pulmonary complications)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105638 0
Prof Kate Leslie
Address 105638 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville, VIC, 3050
Country 105638 0
Australia
Phone 105638 0
+61393427540
Fax 105638 0
Email 105638 0
kate.leslie@mh.org.au
Contact person for public queries
Name 105639 0
Prof Kate Leslie
Address 105639 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville, VIC, 3050
Country 105639 0
Australia
Phone 105639 0
+61393427000
Fax 105639 0
Email 105639 0
kate.leslie@mh.org.au
Contact person for scientific queries
Name 105640 0
Prof Kate Leslie
Address 105640 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville, VIC, 3050
Country 105640 0
Australia
Phone 105640 0
+61393427000
Fax 105640 0
Email 105640 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 other documents available
Summary results
No Results