None listed
Conditions
Brief summary
The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.
Interventions
Arm 1
Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent.
Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up to a max of 30 days.
Arm 2
Grp Std care- standard care sedation as per site's normal practice. Given via infusion as required.
Sponsors
ANZIC-research centre, Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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 - Patient’s mean arterial blood (MAP) pressure is less than 55 mmHg despite resuscitation and vasopressor therapy - Patient has a heart rate (HR) less than 55/min unless being treated with a beta blocker - Patient has a high grade atrio-ventricular block in the absence of a functioning pacemaker - Patient has end stage liver failure or acute fulminant hepatic failure - Patient does not speak English - Death is deemed imminent and inevitable -Patient is a nursing home resident - Patient has an underlying disease that makes survival to 90 days unlikely.
Outcome results
None listed