Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study

Phase 2

• Conditions: Other - Research that is not of generic health relevance and not applicable to specific health categories listed above; Sedation in intensive care patients; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12611000166976
• Lead Sponsor: ANZIC-research centre, Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a comparison of the cumulative and daily dose of administered dexmedetomidine and midazolam in the intervention and the control groups.<br>This will be assessed via data collected from the medical record.[At discharge from intensive care.]