Data

SNaPP Pilot Study 2021 Trial Dataset

The University of Melbourne

Dataset 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.
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Subjects

Anaesthesiology |

Source Study

Trial 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 ....
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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 ....
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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 ....
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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 ....
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Outcomes

Outcome: Rate of recruitment of eligible patients who were approached for consent to participate, as recorded in screening log
Timepoint: At the time of attempted recruitment between booking for surgery and arrival in the operating room

Study Protocol: Not Available
Data Dictionary: Not Available

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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au