Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000084583
Ethics application status
Approved
Date submitted
25/02/2006
Date registered
1/03/2006
Date last updated
1/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The neuro-behavioural effects of Dexmedetomidine Vs Morphine in adult patients after cardiac surgery
Scientific title
The neuro-behavioural effects of Dexmedetomidine Vs Morphine in adult patients after cardiac surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium post cardiac surgery 1048 0
Condition category
Condition code
Cardiovascular 1127 1127 0 0
Other surgery
Neurological 1128 1128 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive intravenous morphine 30-70 mic/kg/hr infusion, up to 48hrs.
Intervention code [1] 922 0
Treatment: Drugs
Comparator / control treatment
Patients will receive intravenous Dexmedetomidine 0.3-0.7 mic/kg/hr infusion, up to 48hrs.
Control group
Active

Outcomes
Primary outcome [1] 1512 0
Delirium Rate as assessed using the Intensive care Confusion Assessment Method (CAM-ICU. Delirium will be stratified into hypo, hyper-active or severe agitation.
Timepoint [1] 1512 0
Days 1, 3 and 5.
Secondary outcome [1] 2711 0
1. Lengths of ICU stay.
Timepoint [1] 2711 0
Secondary outcome [2] 2712 0
2. Time to extubation in ICU.
Timepoint [2] 2712 0
Secondary outcome [3] 2713 0
3. Lengths of hospital stay.
Timepoint [3] 2713 0
Secondary outcome [4] 2714 0
4. In hospital mortality rate.
Timepoint [4] 2714 0
Secondary outcome [5] 2715 0
5. Self-extubationin ICU.
Timepoint [5] 2715 0
Secondary outcome [6] 2716 0
6. Intubation period beyond 12 hrs in ICU.
Timepoint [6] 2716 0

Eligibility
Key inclusion criteria
Patients undergoing cardiac surgery on bypass including CABG, valve surgery, combination CABG and/or valve replacement procedures.·Patients who have given consent.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to any of the trial drugs.·Creatinine >134 mmol/L or creatinine clearance calculated by Cockcroft Gault formula of <50ml/min·Receiving other alpha 2 agonists like Clonidine.·Patients on psychotic drugs other than night time hypnotics.·Pre operative dementia/ Parkinsonism/ Other cerebral illness.·Non English speaking patients.·Weight greater than 150 Kgs.·Surgery involving intracranial vasculature within last 3 months·Surgery involving free flap within last 3 months ·Receiving neuromuscular blockers for reasons other than performing endotracheal intubation.·Patients receiving regional analgesia·Haemodynamic instability, i.e. HR < 55 beats per minute, Systolic blood pressure < 90 mmHg.·Failure to obtain consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomised sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generation in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1230 0
Charities/Societies/Foundations
Name [1] 1230 0
Intensive care research fund
Country [1] 1230 0
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 1087 0
None
Name [1] 1087 0
Nil
Address [1] 1087 0
Country [1] 1087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2559 0
Prince of Wales Hospital Ethics
Ethics committee address [1] 2559 0
Ethics committee country [1] 2559 0
Australia
Date submitted for ethics approval [1] 2559 0
Approval date [1] 2559 0
20/05/2004
Ethics approval number [1] 2559 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35184 0
Address 35184 0
Country 35184 0
Phone 35184 0
Fax 35184 0
Email 35184 0
Contact person for public queries
Name 10111 0
Naomi Hammond
Address 10111 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10111 0
Australia
Phone 10111 0
+61 2 93824720
Fax 10111 0
Email 10111 0
naomi.hammond@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1039 0
Dr Yahya Shehabi
Address 1039 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1039 0
Australia
Phone 1039 0
+61 2 93824721
Fax 1039 0
Email 1039 0
yshehabi@ozemail.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.