Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000199213
Ethics application status
Approved
Date submitted
16/02/2009
Date registered
21/04/2009
Date last updated
6/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising post-operative sedation for Cardiac Intensive Care in patients undergoing elective cardiac surgery involving cardiopulmonary bypass.
Scientific title
The effect of Dexmedetomidine versus Propofol in optimising post-operative sedation in patients undergoing elective cardiac surgery involving cardiopulmonary bypass.
Secondary ID [1] 283710 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
OSCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative sedation 4332 0
Condition category
Condition code
Anaesthesiology 4569 4569 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmedetomidine - Intravenous dexmedetomidine as a continuous infusion of 0.2-2.5 mcg/kg/h titrated to effect (level of sedation) from end of surgery until weaning for extubation from mechanical ventilation.
Intervention code [1] 4061 0
Treatment: Drugs
Comparator / control treatment
Propofol (standard treatment) - Intravenous propofol as a continuous infusion of 1-3 mg/kg/h titrated to effect (level of sedation) from the end of surgery until weaning for extubation from mechanical ventilation.
Control group
Active

Outcomes
Primary outcome [1] 5450 0
Concentration effect relationship for dexmedetomidine and sedation, blood pressure & heart rate. Concentration of drug will be measured by Liquid Chromatrogrphy-Mass Spectrometry-Mass Spectrometry (LC-MS-MS) assay and concentration-effect relationship for Pharmacodynamic parameters will be modelled using Non Linear Mixed Effects Models.
Timepoint [1] 5450 0
0, 5, 10, 15, 20, 30, 45, 60 minutes, 2 and 3 hours following termination of drug infusion
Secondary outcome [1] 9148 0
Effect of dexmedetomidine on sleep-wake cycles and sleep disturbance in the Intensive Care Unit (ICU). Sleep will be measured using Actigarphy and Processed Electroencephalography (EEG) (Bisprectral Index (BIS)) monitoring.
Timepoint [1] 9148 0
Sleep will be continuously monitored for up to 2 days post-operation.

Eligibility
Key inclusion criteria
Any patient undergoing elective cardiac surgery involving cardipulmonary bypass 18 years or older who provides written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-allergic to alpha-2 adronoceptor agonists
-alltergic to propofol
-known to be pregnant or breastfeeding
-history of drug abuse
-enrolled in another clinical trial

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)
Patients will be identified from surgical lists, approched and have the study explained. If they wish to participate written informed consent will be obtained. Patients will then be randomised via sealed envelopes to receive dexmedetomidine or propofol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1572 0
New Zealand
State/province [1] 1572 0

Funding & Sponsors
Funding source category [1] 4504 0
Charities/Societies/Foundations
Name [1] 4504 0
The Green Lane Research and Educational Fund
Country [1] 4504 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 4067 0
None
Name [1] 4067 0
Address [1] 4067 0
Country [1] 4067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6565 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6565 0
Private Bag 92 522
Wellesley Street 1141
Auckland
Ethics committee country [1] 6565 0
New Zealand
Date submitted for ethics approval [1] 6565 0
Approval date [1] 6565 0
17/11/2008
Ethics approval number [1] 6565 0
NTX/08/10/094

Summary
Brief summary
The primary purpose of this study is to investigate the concentration effect relationship for dexmedetomidine and sedation, heart rate and blood pressure in adult patients undergoing elective cardiac surgery involving cardiopulmonary bypass as this is previously unreported. We also want to examine the effect of dexmedetomidine on postoperative sleep wake cycles compared to propofol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29290 0
Dr Amanda Potts
Address 29290 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland 1142
Country 29290 0
New Zealand
Phone 29290 0
+64 9 373 7599 ext 89305
Fax 29290 0
Email 29290 0
[email protected]
Contact person for public queries
Name 12537 0
Dr Amanda Potts
Address 12537 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NZ
Country 12537 0
New Zealand
Phone 12537 0
+64 9 373 7599 extn 89305
Fax 12537 0
Email 12537 0
[email protected]
Contact person for scientific queries
Name 3465 0
Dr Amanda Potts
Address 3465 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NZ
Country 3465 0
New Zealand
Phone 3465 0
+64 9 373 7599 ext 89305
Fax 3465 0
Email 3465 0
[email protected]

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.