A randomised controlled trial of a sedative regimen that utilises dexmedetomidine as the primary agent and minimises the use of midazolam compared with current sedation practice in intensive care patients on outcomes of mortality, cognitive function and Health Related Quality of Life.

ANZIC-research centre, Monash University0 sites60 target enrollmentFebruary 11, 2011

Overview

No summary available.

Registry

who.int

Start Date

February 11, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

ANZIC-research centre, Monash University

•Patients eligible for the study must meet these 2 criteria:
•The patient is mechanically ventilated via an endotracheal tube and has been intubated, (excluding time spent intubated within an operating or procedural theatre), for less than 12 hours, and the treating clinician believes that:
•1\.The patient requires immediate AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
•2\.The choice of the sedative medications needs to be determined now
•3\.There is uncertainty whether a sedative regimen using dexmedetomidine as the primary agent or the clinicians usual choice of sedative regimen for this patient is superior, AND
•4\.The patient is expected to remain intubated the day after tomorrow.

•Patients will be excluded from the study if any of the following criteria apply:
•\- Age less than 18 years,
•\- Patient is pregnant and/or lactating.
•\- Patient has a proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
•\- Patient has a proven or suspected cervical spinal cord injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
•\- Patient has proven or suspected primary neurological pathology associated with prolonged weakness, such as Guillain\-Barre syndrome
•\- Patient has been admitted as a consequence of a drug overdose
•\- Patient has burn injuries
•\- Patient is receiving or expected to need ongoing neuromuscular blockade
•\- Patient has allergy to propofol or dexmedetomidine