ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12620000515998p

Ethics application status

Submitted, not yet approved

Date submitted

31/03/2020

Date registered

27/04/2020

Date last updated

27/04/2020

Date data sharing statement initially provided

27/04/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Larger dose Rocuronium (2mg/kg) versus standard dose (1mg/kg) Rocuronium for speed of onset of paralysis and quality of intubating conditions in Rapid Sequence Intubation (RSI) in adults having surgery.

Scientific title

Onset time of Rocuronium 2mg/kg versus 1mg/kg for Rapid Sequence Intubation
in adults having surgery requiring intubation.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intubation

Rapid Sequence Intubation (RSI)

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Blinded randomised parallel trial of Rocuronium by single intravenous bolus injection over 5 seconds by anaesthetist of 2mg/kg at induction versus 1mg/kg for Rapid Sequence Intubation. Timings of injection and outcome measures overseen by second practitioner.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control standard therapy Rocuronium 1mg/kg

Control group

Active

Outcomes

Primary outcome [1]

Time to loss of single twitch electromyography 70mA one per second on ulnar nerve/adductor policis.

Timepoint [1]

Immediately following injection

Secondary outcome [1]

Grade of Intubating Conditions measured as described in "Fuchs-Buder T et al. 2007. Good Clinical practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand 51:789-808". Jaw relaxation, vocal cord position and diaphragm reaction will be graded as excellent, good or poor and the worst grade recorded for that intubation overall.

Timepoint [1]

At 60 seconds from the start of the injection of Rocuronium (given over 5s).

Eligibility

Key inclusion criteria

Adults 18-60
BMI <35
ASA 1 & 2
attending for an operation that requires intubation as part of anaesthetic

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

expected difficult airway or contraindication to Rapid Sequence Induction
pregnancy
on medication known to affect cardiac output

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Concealed - envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation table generated by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/01/2021

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)

NSW

Recruitment hospital [1]

Blacktown Hospital - Blacktown

Recruitment postcode(s) [1]

2148 - Blacktown

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

not yet determined - grants applied for

Address [1]

not yet determined

Country [1]

Primary sponsor type

Hospital

Name

Blacktown/Mount Druitt Hospital, WSLHD

Address

Anaesthetics Department,
Blacktown Hospital,
Blacktown Road,
Blacktown
NSW 2148

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

WSLHD Human Research Ethics Committee 
Research Office
Level 2
REN Building
Westmead Hospital
Cnr Hawkesbury & Darcy Roads
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Many patients undergo emergency intubations, also called Rapid Sequence Intubations (RSI), where a breathing tube is placed into their windpipe to provide oxygen to their lungs, both in hospital and at the roadside. To place a breathing tube requires the muscles of the voice box to be paralysed.

Which drug and dose is best for this paralysis has undergone much debate and many studies. Rocuronium manufacturers suggest 1mg/kg will suffice to paralyse patients for RSI and this has become current anaesthetic and emergency department standard practice. 

Studies reveal 1mg/kg Rocuronium paralysis at 60seconds to be ‘adequate’ rather than ‘excellent’ however, as judged by those doing the intubations. Mathematical calculations based on patient data revealed that a dose of 1.8 – 2.3 mg/kg Rocuronium may be needed to achieve ‘excellent’ intubating conditions at 60 seconds in at least 90-95% of people. 

This study will ask how quickly 2mg/kg Rocuronium works compared to 1mg/kg and if that is better for Rapid Sequence Intubations. The time taken for paralysis effect in muscles can be measured in seconds, and anaesthetists can rate the quality of intubating conditions at 60s. If Rocuronium 2mg/kg proves to be reasonably faster and more effective than 1mg/kg, then this information could change the dose of Rocuronium given not only at prehospital emergency intubations but also in any operating theatre or intensive care unit when speed of action matters.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Clare Hayes-Bradley

Address

c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148

Country

Australia

Phone

+61 286708019

Fax

clare.hayesbradley@health.nsw.gov.au

Contact person for public queries

Name

Clare Hayes-Bradley

Address

c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148

Country

Australia

Phone

+61 286708019

Fax

clare.hayesbradley@health.nsw.gov.au

Contact person for scientific queries

Name

Clare Hayes-Bradley

Address

c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148

Country

Australia

Phone

+61 286708019

Fax

clare.hayesbradley@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

no current plan to share, no requests made

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

No additional documents have been identified.

Trial Review

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Documents added manually

Documents added automatically