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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Dexmedetomidine on MAAS in severely agitated, mechanicaaly ventilated, critically ill patients
Scientific title
The effect of Dexmedetomidine on MAAS in severely agitated, mechanicaaly ventilated, critically ill patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in mechanically ventilated ICU patients. 1050 0
Condition category
Condition code
Other 1130 1130 0 0

Study type
Description of intervention(s) / exposure
Patients who meet the inclusion creteria were given a continuous intravenous infusion of Dexmedetomidine (0.4 - 1.0mic/kg/hr) up to 7 days.
Intervention code [1] 920 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group

Primary outcome [1] 1515 0
Motor Activity Assessment Score (MASS)
Timepoint [1] 1515 0
At 6 and 12 hours
Secondary outcome [1] 2729 0
1. Length of mechanical ventilation in ICU
Timepoint [1] 2729 0
Secondary outcome [2] 2730 0
2. Ventilation time pre Dexmedetomidine in ICU
Timepoint [2] 2730 0
Secondary outcome [3] 2731 0
3. Ventilation time post Dexmedetomidine in ICU
Timepoint [3] 2731 0
Secondary outcome [4] 2732 0
4. Number of patients extubated whilst on Dexmedetomidine in ICU
Timepoint [4] 2732 0
Secondary outcome [5] 2733 0
5. Number of tracheostomy in ICU
Timepoint [5] 2733 0
Secondary outcome [6] 2734 0
6. Number of self extubation in ICU
Timepoint [6] 2734 0
Secondary outcome [7] 2735 0
7. Number of reintubations in ICU
Timepoint [7] 2735 0
Secondary outcome [8] 2736 0
8. Use of other sedatives in ICU
Timepoint [8] 2736 0
Secondary outcome [9] 2737 0
9. Use of vasopressor and vasodilator infusions in ICU
Timepoint [9] 2737 0

Key inclusion criteria
1.Patient requiring invasive ventilation for longer than 24 hours. 2.Receiving narcotics and /or sedatives for longer than 24 hours. 3.Development of clinical agitation and/or delirium upon weaning narcotics and/or sedatives on commencement of weaning from mechanical ventilation 4.Informed consent signed by person responsible within 24 hours of enrolment. 5. Have failed conventional sedative therapy as assessed by the treating intensivist.
Minimum age
18 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1.Allergy to Dexmedetomidine.2.Patients who are or likely to be pregnant or lactating.3.Patients receiving other long term alpha 2 agonists.4. Involvement in a sedation study within the last 30 days.5. Known opiate or benzodiazepines dependence, treatment for chronic pain or recent detoxification therapy within the last 6 months. 6. Patients on anti-psychotic drugs 7. Known dementia, Parkinsonism or epilepsy.8. Patients with recent cerebro-vascular surgery or traumatic brain injury.9. Any evidence of critical illness polyneuropathy.10. Recent surgery involving free flap.11. Haemodynamically unstable patients with Systolic blood pressure < 90 mmHg and or Heart rate < 55 / min.12. Patients on CVVHD.13. Patients with hepatic encephalopathy within 14 days.14. Patients with a recent drug overdose or CO poisoning.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1232 0
Name [1] 1232 0
Intensive care research fund
Address [1] 1232 0
Country [1] 1232 0
Primary sponsor type
Prince of Wales Hospital
Secondary sponsor category [1] 1089 0
Name [1] 1089 0
Address [1] 1089 0
Country [1] 1089 0

Ethics approval
Ethics application status

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35380 0
Address 35380 0
Country 35380 0
Phone 35380 0
Fax 35380 0
Email 35380 0
Contact person for public queries
Name 10109 0
Naomi Hammond
Address 10109 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10109 0
Phone 10109 0
+61 2 93824720
Fax 10109 0
Email 10109 0
Contact person for scientific queries
Name 1037 0
Dr Yahya Shehabi
Address 1037 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1037 0
Phone 1037 0
+61 2 93824721
Fax 1037 0
Email 1037 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary