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Trial registered on ANZCTR


Registration number
ACTRN12618001122246p
Ethics application status
Not yet submitted
Date submitted
28/06/2018
Date registered
6/07/2018
Date last updated
6/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two different sedation techniques (midazolam or no-midazolam) to sedate patients undergoing electrical shock for arrhythmia
Scientific title
Midazolam vs placebo for sedation for elective cardioversion, effect on awareness and airway complications
Secondary ID [1] 295349 0
Nil known
Universal Trial Number (UTN)
U1111-1216-3967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 308564 0
Atrial flutter 308565 0
Condition category
Condition code
Cardiovascular 307521 307521 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be those already admitted to the Critical Care Ward of Toowoomba Hospital for the purposes of electrical cardioversion for a stable atrial arrhythmia. Their participation in the trial will not involve any additional stay in hospital.

Patient will be randomised into one of two groups. One will receive midazolam, fentanyl and propofol. The other will receive placebo, fentanyl and propofol.

The fentanyl dose will be between 20 and 200ug, delivered as a single dose intravenously, with the dose determined by patient factors such as age, weight and co-morbidities.

The propofol dose will be between 20 and 200mg, delivered as small repeated doses (of 10 to 50mg) over between one and five minutes, titrated to patient conscious state.

The midazolam (or placebo) dose will be between 1 and 5mg, delivered as a single intravenous dose, with the dose determined by patient factors (age, weight, co-morbidites and prior alcohol or benzodiazepine exposure).

The medications will be administered in the following order:

Midazolam will be administered as the first medication, and given 1 to 3 minutes to have effect.
Fentanyl will be administered next, and given 30 seconds to one minute to have effect.
Propofol will be the final medication administered, and titrated to effect, with approximately 30 seconds between doses.

All medications will be administered by an intensive care doctor who has received education about the research project. The medications will be prepared by a senior intensive care nurse, with only this nurse being aware whether they have prepared midazolam or placebo (as decided by randomisation via sealed numbered envelopes). The nurse who has prepared the medication will have no role in the administration of the drugs or collecting data relating to the trial.
Intervention code [1] 301671 0
Treatment: Drugs
Comparator / control treatment
Placebo will be used in place of midazolam. This will be prepared by an independent nurse, and will consist of 0.9% saline, with a 'midazolam or placebo' label placed on the syringe.

The fentanyl dose will be between 20 and 200ug, delivered as a single dose intravenously, with the dose determined by patient factors such as age, weight and co-morbidities.

The propofol dose will be between 20 and 200mg, delivered as small repeated doses (of 10 to 50mg) over between one and five minutes, titrated to patient conscious state.

The timing of the medication administration will be identical to the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 306498 0
Requirement for any airway or respiratory support. This is a composite of a number of secondary outcomes.

This will be assessed by direct observation by a clinician who has received education regarding the trial. Data collection will be performed contemporaneously with the sedation procedure.
Timepoint [1] 306498 0
During the sedation procedure (approximately ten minutes)
Primary outcome [2] 306499 0
Awareness of electrical shock/pain during cardioversion

This will be assessed after the sedation procedure has been completed and the patient has recovered enough to be alert without stimulus, and aware of their surroundings. They will be asked if they have any memory of the electrical cardioversion, and if so will be asked how unpleasant it was on a scale from 1 to 10.
Timepoint [2] 306499 0
This will be assessed between five and sixty minutes after the procedure, after the patient is deemed to have fully recovered from their sedation.
Secondary outcome [1] 348688 0
Desaturation below 90%, determined by direct observation of the saturations as recorded continuously on the bedside monitor.
Timepoint [1] 348688 0
During the sedation procedure (approximately ten minutes)
Secondary outcome [2] 348689 0
Desaturation below 80%, determined by direct observation of the saturations as recorded continuously on the bedside monitor.
Timepoint [2] 348689 0
During the sedation procedure (approximately ten minutes)
Secondary outcome [3] 348690 0
Requirement for bag-mask ventilation, determined by direct observation of the patient by a trained observer.
Timepoint [3] 348690 0
During the sedation procedure (approximately ten minutes)
Secondary outcome [4] 348691 0
Requirement for airway adjunct (Guedel's airway, nasopharyngeal airway), determined by direct observation of the patient by a trained observer.
Timepoint [4] 348691 0
During the sedation procedure (approximately ten minutes)
Secondary outcome [5] 348692 0
Hypotension below systolic pressure 90, determined by direct observation of the blood pressure on the bedside monitor, with a non-invasive blood pressure taken at least every 2.5 minutes, and observed by a trained observer.
Timepoint [5] 348692 0
During the sedation procedure (approximately ten minutes)
Secondary outcome [6] 348693 0
Time to patient obeying commands post cardioversion, as observed by a trained observer. The patient will be asked to raise both arms off the bed, and will meet the requirements if both elbows are seen to be supported against gravity.
Timepoint [6] 348693 0
During the sedation procedure (approximately ten minutes)

Eligibility
Key inclusion criteria
Admission to the Critical Care ward for non-emergent cardioversion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Reduced cardiorespiratory reserve such that a potentially higher dose of propofol required in the absence of midazolam may be detrimental

Contraindiation to use of any of the intended sedative drugs (midazolam, an opiate, propofol)

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)
Simple randomisation by shuffling of sealed envelopes prior to study commencement
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size of 102 patients will give an 80% power to detect a 50% reduction in the need for airway support, with a p-value of 0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11259 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 23137 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 299942 0
Hospital
Name [1] 299942 0
Toowoomba Hospital
Country [1] 299942 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Visser
Address
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Australia
Country
Australia
Secondary sponsor category [1] 299319 0
Individual
Name [1] 299319 0
Dr Chris Wagner
Address [1] 299319 0
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Australia
Country [1] 299319 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300809 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300809 0
Ethics committee country [1] 300809 0
Australia
Date submitted for ethics approval [1] 300809 0
23/07/2018
Approval date [1] 300809 0
Ethics approval number [1] 300809 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84882 0
Dr Adam Visser
Address 84882 0
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Country 84882 0
Australia
Phone 84882 0
+61 7 4616 6422
Fax 84882 0
+61 7 4616 6071
Email 84882 0
[email protected]
Contact person for public queries
Name 84883 0
Adam Visser
Address 84883 0
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Country 84883 0
Australia
Phone 84883 0
+61 7 4616 6422
Fax 84883 0
+61 7 4616 6071
Email 84883 0
[email protected]
Contact person for scientific queries
Name 84884 0
Adam Visser
Address 84884 0
c/o Critical Care Ward
Toowoomba Hospital
Pechey Street
Toowoomba, Queensland 4350
Country 84884 0
Australia
Phone 84884 0
+61 7 4616 6422
Fax 84884 0
+61 7 4616 6071
Email 84884 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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