Trial Review

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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] 300902 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation 316838 0
Rapid Sequence Intubation (RSI) 316839 0
Condition category
Condition code
Anaesthesiology 315045 315045 0 0
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] 317220 0
Treatment: Drugs
Comparator / control treatment
Control standard therapy Rocuronium 1mg/kg
Control group
Active

Outcomes
Primary outcome [1] 323347 0
Time to loss of single twitch electromyography 70mA one per second on ulnar nerve/adductor policis.
Timepoint [1] 323347 0
Immediately following injection
Secondary outcome [1] 381621 0
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] 381621 0
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?
No
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
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16182 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 29725 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 305351 0
Self funded/Unfunded
Name [1] 305351 0
not yet determined - grants applied for
Country [1] 305351 0
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] 305722 0
None
Name [1] 305722 0
Address [1] 305722 0
Country [1] 305722 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305683 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305683 0
WSLHD Human Research Ethics Committee
Research Office
Level 2
REN Building
Westmead Hospital
Cnr Hawkesbury & Darcy Roads
Westmead NSW 2145
Ethics committee country [1] 305683 0
Australia
Date submitted for ethics approval [1] 305683 0
14/04/2020
Approval date [1] 305683 0
Ethics approval number [1] 305683 0

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 101214 0
Dr Clare Hayes-Bradley
Address 101214 0
c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148
Country 101214 0
Australia
Phone 101214 0
+61 286708019
Fax 101214 0
Email 101214 0
[email protected]
Contact person for public queries
Name 101215 0
Clare Hayes-Bradley
Address 101215 0
c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148
Country 101215 0
Australia
Phone 101215 0
+61 286708019
Fax 101215 0
Email 101215 0
[email protected]
Contact person for scientific queries
Name 101216 0
Clare Hayes-Bradley
Address 101216 0
c/o Anaesthetic Department
Blacktown Hospital
Blacktown Road,
Blacktown
NSW 2148
Country 101216 0
Australia
Phone 101216 0
+61 286708019
Fax 101216 0
Email 101216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.