Status:
COMPLETED
Propranolol as an Anxiolytic to Reduce the Use of Sedatives From Critically-ill Adults Receiving Mechanical Ventilation
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Hamilton Health Sciences Corporation
The Ottawa Hospital
Conditions:
Mechanical Ventilation
Sedation
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The COVID-19 pandemic has led to shortages of intravenous sedatives due to increased ICU patient admissions and greater use of mechanical ventilation. A shortage of sedatives is as concerning as a sho...
Detailed Description
Background and Rationale: Critically ill patients often require sedation for comfort and to tolerate mechanical ventilation. There are internationally accepted guidelines for sedation of critically i...
Eligibility Criteria
Inclusion
- Adult patients admitted to an intensive care unit requiring mechanical ventilation and anticipated to require mechanical ventilation \>48h
- Patient has a sedation target (e.g. using the Richmond Agitation Sedation Scale or Sedation Agitation Scale) that is anticipated to be stable \>48h
- Minimum sedative infusion doses (any one of):
- Propofol \>/=1.5 mg/kg/h \>24h
- Midazolam \>/=3.0 mg/h \>24h
Exclusion
- Sedation for paralysis
- Use of neuromuscular blocking agents (patients may be eligible once these are discontinued)
- Asthma or known reactive airways disease
- 1st, 2nd or 3rd-degree heart block (with no permanent pacemaker) at the time of screening
- Known history of congestive heart failure with ejection fraction \<20%
- HR\<60 bpm at baseline
- Hypotension requiring vasopressor support above the following levels
- Norepinephrine dose \>0.15mcg/kg/min or equivalent (\>0.15mcg/kg/min epinephrine; \>22.5 mcg/kg/min dopamine; \>0.06 U/min vasopressin)
- Phenylephrine \>2.0 mcg/kg/min
- Receiving 3 or more vasopressors, regardless of dose
- Pregnancy or lactation
- Allergy to propranolol
- Patients for whom an enteral route of drug administration is not available
- Patients who are on digoxin, diltiazem, or verapamil
- Patients on chronic betablockers are eligible for enrolment. Patients allocated to the intervention arm will have their betablocker replaced with propranolol. Once propranolol is discontinued, the treating team may resume their usual betablocker. Control patients may continue their usual betablocker (unless it is propranolol) at the treating team's discretion.
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04467086
Start Date
January 8 2021
End Date
November 30 2022
Last Update
December 5 2022
Active Locations (2)
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1
Hamilton Health Sciences Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8M8