None listed
Conditions
Brief summary
Patients who present for elective/non-emergent electrical cardioversion for atrial arrhythmias require sedation for the procedure. A combination of drugs, often including midazolam, a sedative that causes respiratory depression, is typically used. We hypothesise that removing midazolam from the combination of drugs used will result in a lower need for airway and breathing rescue techniques, without increasing patient's memory for the cardioversion procedure.
Interventions
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,
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.
Sponsors
Dr Adam Visser
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Admission to the Critical Care ward for non-emergent cardioversion
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)
Outcome results
None listed