SNaPP Pilot Study 2021 Trial Dataset
The University of MelbourneDataset description
Demographics, comorbidities, intraoperative and postoperative data for 120 particpants from the SNaPP Pilot Study. Male and female participants aged 40 years and over and presenting for abdominal or thoracic surgery under relaxant general anaesthesia. Assessed at hospital discharge, or after 7 days if still in hospital, for the primary outcome (postoperative pulmonary complications); at 30 days for days alive and at home and at 3 months for quality of life.Subjects
Anaesthesiology |Identifiers
Source Study
Trial name (public)
Sugammadex, neostigmine and postoperative pulmonary complications (SNaPP): a feasibility and pilot trialTrial acronym
The SNaPP Pilot Study
Trial ID
ACTRN12620001313921
Purpose
Prevention
Phase
Phase 4
Funding
Charities/Societies/Foundations,Australian and New Zealand College of Anaesthetists
Scientific enquiries
Prof Kate Leslie
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 fewe .... Read more
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
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 blockad .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 120
Min. age 40 Years
Max. age No limit
Sex Both males and females
Condition category Acute respiratory distress syndrome , Pneumonia , Pulmonary aspiration , Pulmonary atelectasis , Respiratory
Condition code Anaesthesiology , Respiratory , Surgery
Intervention
Intervention code Prevention
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 .... Read more
Comparison
Control group Active
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 neostigmin .... Read more
Outcomes
Outcome: Rate of recruitment of eligible patients who were approached for consent to participate, as recorded in screening logTimepoint: At the time of attempted recruitment between booking for surgery and arrival in the operating room
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All data except for identifying variables
When will data be available?
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