Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000087853
Ethics application status
Approved
Date submitted
6/01/2012
Date registered
17/01/2012
Date last updated
17/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anaesthesia practice since introduction of sugammadex: has it changed patient outcome?
Scientific title
Patient outcome after reversal of residual neuromuscular blockade with either neostigmine or no reversal agent vs. reversal with sugammadex.
Secondary ID [1] 279674 0
nil
Universal Trial Number (UTN)
U1111-1126-8681
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual neuromuscular blockade, its reversal and associated patient outcome 285495 0
Condition category
Condition code
Anaesthesiology 285682 285682 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational trial.
We aim to retrospectively investigate outcome parameters (incidence of pulmonary complications postoperatively, length of stay in the recovery room/the hospital) and incidence of adverse airway events in the recovery room) in postoperative patients who received reversal of neuromuscular paralysis with either neostigmine or no reversal agent or sugammadex.

Data will be collected from patients' medical records, an electronic theatre management system (e.g. anaesthesia times, length of stay) and an electronic medical results system (ISOFT; e.g. white cell count and chest-xray reports). Data collection will include patients whose surgery took place from 1.3.11 until present. Data collection will include consecutive patients until the sample size per group has been achieved.
Intervention code [1] 283964 0
Not applicable
Comparator / control treatment
Both, reversal with neostigmine or the administration of no reversal agent will serve as (combined) "control"
Control group
Active

Outcomes
Primary outcome [1] 286221 0
Incidence of postoperative pulmonary complications within 30 days (assessed via an electronic record keeping software ,ISOFT, which allows access to patients' chest xray reports). In addition, we will investigate patients' medical records to see whether any clinical signs of adverse pulmonary outcome (e.g. coughing, increased oxygen demand) where observed postoperatively.
Timepoint [1] 286221 0
within 30 days post operation (data assessed post-hoc = from medical records [pelectronic/paper] after at least 30 days from surgery)
Secondary outcome [1] 295407 0
length of stay in the recovery room/the hospital (assessed via both electronic and paper medical records in which the outcome parameters are automatically recorded).
Timepoint [1] 295407 0
at any time during the study period, but at least 30 days after a patients operation
Secondary outcome [2] 295408 0
adverse airway events (oxygen desaturation, need for anaesthetist airway review/ventilation, respiratory arrest)
Timepoint [2] 295408 0
at least 30 days after surgery (via electronic/paper medical records)

Eligibility
Key inclusion criteria
Patients operated at Royal Perth Hospital and tracheally intubated with the use of a neuromuscular blocking agent. Hereby the reason for the operation (= original medical condition leading to treatment) is unimportant
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with significant multi-trauma, cardiothoracic surgery and patients who arrive in or leave theatres intubated

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284460 0
Self funded/Unfunded
Name [1] 284460 0
Thomas Ledowski
Country [1] 284460 0
Australia
Primary sponsor type
Individual
Name
Thomas Ledowski
Address
Dept. of Anaesthesia
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 283386 0
None
Name [1] 283386 0
Address [1] 283386 0
Country [1] 283386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286436 0
Human Ethics committee of the Royal Perth Hospital
Ethics committee address [1] 286436 0
Royal Perth Hospital
Colonial House
Murray Street
Perth WA 6000
Ethics committee country [1] 286436 0
Australia
Date submitted for ethics approval [1] 286436 0
Approval date [1] 286436 0
21/12/2011
Ethics approval number [1] 286436 0
2011/145

Summary
Brief summary
The drug sugammadex (Bridion) has recently been introduced into clinical practice at the Royal Perth Hospital (RPH). This drug provides the anaesthetist with a new and very efficient way of reversing the effects of amino-steroidal neuromuscular blocking agents.
If not completely reversed, the residual effects of muscle relaxants are known to significantly impair postoperative patient outcome (Murphy et al. , Anesthesia and Analgesia 2010; 111: 120-8).
Unfortunately, when muscle relaxants are either not reversed or neostigmine is used, the incidence of such residual paralysis is extremely high (50-60% at RPH 2011, own pilot data)! This is at least partially due to a lack of appropriate monitors (already highlighted this matter to hospital and monitors are being bought) but also the lack of a reliable muscle relaxant antagonist. The latter may have changed since introduction of sugammadex in Australia in 2010.

In a just completed audit we found strong evidence for a potential of sugammadex to result in better postoperative outcomes (lower incidence of residual neuromuscular blockade and lower incidence of postoperative pneumonia/atelectasis). However, the numbers investigated were too low to draw final conclusions. Based on this pilot data we will need to investigate at least 721 cases with the use of sugammadex and compare them with at least 721 control cases in whom no or a different reversal drug (neostigmine) has been used. This equals the investigation of data from patients intubated at RPH over approx. 12 months.


The goal of this retrospective study is to build on our previous audit and investigate whether the use of sugammadex indeed resulted in beneficial patient outcomes over the last 12 months.


For this purpose, the data review will identify all eligible patients who received neuromuscular blocking agents and the mode of its reversal at the end of surgery. Main outcome data are adverse events in the recovery room, within 30 days after surgery (lung associated complications) and length of stay (recovery/hospital).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33588 0
Address 33588 0
Country 33588 0
Phone 33588 0
Fax 33588 0
Email 33588 0
Contact person for public queries
Name 16835 0
Prof. Thomas Ledowski
Address 16835 0
Depot. of Anaesthesia
Royal Perth Hospital
Perth WA 6000
Country 16835 0
Australia
Phone 16835 0
0061 8 9224 1037
Fax 16835 0
Email 16835 0
[email protected]
Contact person for scientific queries
Name 7763 0
Prof. Thomas Ledowski
Address 7763 0
Depot. of Anaesthesia
Royal Perth Hospital
Perth WA 6000
Country 7763 0
Australia
Phone 7763 0
0061 8 9224 1037
Fax 7763 0
Email 7763 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
SourceTitleYear of PublicationDOI
Dimensions AIRetrospective investigation of postoperative outcome after reversal of residual neuromuscular blockade2014https://doi.org/10.1097/eja.0000000000000010
N.B. These documents automatically identified may not have been verified by the study sponsor.