ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

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]

within 30 days post operation (data assessed post-hoc = from medical records [pelectronic/paper] after at least 30 days from surgery)

Secondary outcome [1]

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]

at any time during the study period, but at least 30 days after a patients operation

Secondary outcome [2]

adverse airway events (oxygen desaturation, need for anaesthetist airway review/ventilation, respiratory arrest)

Timepoint [2]

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?

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]

Self funded/Unfunded

Name [1]

Thomas Ledowski

Address [1]

Dept. of Anaesthesia
Royal Perth Hospital
Wellington Street
Perth WA 6000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Ethics committee of the Royal Perth Hospital

Ethics committee address [1]

Royal Perth Hospital
Colonial House
Murray Street
Perth WA 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/12/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof. Thomas Ledowski

Address

Depot. of Anaesthesia
Royal Perth Hospital
Perth WA 6000

Country

Australia

Phone

0061 8 9224 1037

Fax

[email protected]

Contact person for scientific queries

Name

Prof. Thomas Ledowski

Address

Depot. of Anaesthesia
Royal Perth Hospital
Perth WA 6000

Country

Australia

Phone

0061 8 9224 1037

Fax

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Retrospective investigation of postoperative outcome after reversal of residual neuromuscular blockade	2014	https://doi.org/10.1097/eja.0000000000000010

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically