Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001215617
Ethics application status
Not yet submitted
Date submitted
10/11/2014
Date registered
19/11/2014
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How long rocuronium lasts when given subcutaneously to adult surgical patients
Scientific title
A double-blinded randomised clinical trial comparing the time of onset, duration and clinical effects of subcutaneous vs intravenous rocuronium in adult surgical patients
Secondary ID [1] 285619 0
None
Universal Trial Number (UTN)
U1111-1163-8835
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadvertent subcutaneous injection of rocuronium 293467 0
Condition category
Condition code
Anaesthesiology 293748 293748 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.6mg/kg subcutaneous rocuronium, single bolus dose administered following induction of anaesthesia prior to commencement of surgery
Intervention code [1] 290572 0
Treatment: Drugs
Comparator / control treatment
0.6mg/kg intravenous rocuronium, single bolus dose administered following induction of anaesthesia prior to commencement of surgery
Control group
Active

Outcomes
Primary outcome [1] 293545 0
Duration of muscle relaxation until train-of-four ratio recovers to 90% as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [1] 293545 0
Every 5 minutes during surgery until muscle relaxation resolves
Secondary outcome [1] 311332 0
Time from administration of rocuronium until train-of-four count falls to 0/4 as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [1] 311332 0
Every 20 seconds following administration of rocuronium until specified degree of muscle relaxation occurs
Secondary outcome [2] 311333 0
Greatest degree of muscle relaxation produced by rocuronium as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [2] 311333 0
Every 20 seconds following administration of rocuronium until greatest degree of muscle relaxation occurs
Secondary outcome [3] 311334 0
Time from administration of rocuronium until the greatest degree of muscle relaxation occurs as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [3] 311334 0
Every 20 seconds following administration of rocuronium until greatest degree of muscle relaxation occurs
Secondary outcome [4] 311335 0
Time from administration of rocuronium until a train-of-four count of 1/4 returns as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [4] 311335 0
Every 5 minutes during surgery until muscle relaxation recovers to a train-of-four count of 1/4
Secondary outcome [5] 311336 0
Time from administration of rocuronium until a train-of-four count of 2/4 returns as measured by NMT (neuro-muscular transmission) kinemyography monitor
Timepoint [5] 311336 0
Every 5 minutes during surgery until muscle relaxation recovers to a train-of-four count of 2/4
Secondary outcome [6] 311337 0
Time from administration of rocuronium until the first twitch height recovers from 25% of baseline to 75% of baseline as measured by NMT (neuro-muscular transmission) kinemyography monitor (recovery index)
Timepoint [6] 311337 0
Every 5 minutes during surgery until muscle relaxation recovers from a first twitch of 25% to 75% of baseline

Eligibility
Key inclusion criteria
Elective or semi-elective surgery (surgery not required within 24 hours of being booked)
Age 18-64
Expected duration of anaesthesia >6 hours
Planned admission to the intensive care unit after surgery
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery (surgery within 24 hours of procedure being booked)
Patients unable to give informed consent
Severe renal impairment (eGFR <30ml/min)
Significant hepatic impairment (known history of cirrhosis or liver dysfunction)
History of neuromuscular disease (e.g. poliomyelitis, myasthenia gravis, eaton-lambert syndrome)
Patients taking long term medications: lithium, phenytoin, carbamazepine
Administration of other muscle relaxant in previous 24 hours (suxamethonium or other non-depolarising muscle relaxant)
Pregnant or breastfeeding women
Patients requiring muscle relaxation to facilitate surgery
Patients having surgery where muscle relaxation is contraindicated
Significant possibility of anaesthetic ending prior to 6 hours (for instance – intra-abdominal surgery that may be abandoned due to disease progression that can only be decided after starting operation)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Sequential trial design until statistical significance (1% level of significance in mean difference in duration of action by student's t-test), up to a maximum of 20 patients.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Safety concerns
Other reasons/comments
Other reasons
Unable to recruit, ethics application never completed - no convenient study population.
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
1/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3131 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 3158 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 8940 0
6150 - Murdoch
Recruitment postcode(s) [2] 8883 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 290214 0
Hospital
Name [1] 290214 0
Department of Anaesthesia,
Fremantle Hospital
Country [1] 290214 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Alma Street,
Fremantle,
WA, 6160
Country
Australia
Secondary sponsor category [1] 288921 0
None
Name [1] 288921 0
Address [1] 288921 0
Country [1] 288921 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291921 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 291921 0
PO Box 480,
Fremantle,
WA, 6959
Ethics committee country [1] 291921 0
Australia
Date submitted for ethics approval [1] 291921 0
04/11/2014
Approval date [1] 291921 0
Ethics approval number [1] 291921 0
14/80

Summary
Brief summary
This study will examine the effects of rocuronium, a non-depolarising muscle relaxant when given subcutaneously.

In this study, we will compare the effects of subcutaneous rocuronium against intravenous rocuronium. We will measure how long until it works, how much effect it has and how long it lasts.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52614 0
Dr Sam Wong
Address 52614 0
Department of Anaesthesia,
Fremantle Hospital,
Alma Street,
Fremantle,
WA, 6160
Country 52614 0
Australia
Phone 52614 0
+61 8 9431 3333
Fax 52614 0
+61 8 9431 2171
Email 52614 0
sam.wong@health.wa.gov.au
Contact person for public queries
Name 52615 0
Dr Sam Wong
Address 52615 0
Department of Anaesthesia,
Fremantle Hospital,
Alma Street,
Fremantle,
WA, 6160
Country 52615 0
Australia
Phone 52615 0
+61 8 9431 3333
Fax 52615 0
+61 8 9431 2171
Email 52615 0
sam.wong@health.wa.gov.au
Contact person for scientific queries
Name 52616 0
Dr Sam Wong
Address 52616 0
Department of Anaesthesia,
Fremantle Hospital,
Alma Street,
Fremantle,
WA, 6160
Country 52616 0
Australia
Phone 52616 0
+61 8 9431 3333
Fax 52616 0
+61 8 9431 2171
Email 52616 0
sam.wong@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.