Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000750280
Ethics application status
Approved
Date submitted
23/04/2009
Date registered
28/08/2009
Date last updated
15/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
How does the addition of Ketamine to propofol for sedation for Transoesophageal Echocardiography followed by cardioversion influence haemodynamics, anaesthesia and patient satisfaction? A randomised controlled trial versus propofol
Scientific title
Do patients undergoing transoesophageal echocardiography followed by cardioversion randomised to a combination of ketamine and propofol, versus propofol alone, have less impairment of left ventricular function?
Secondary ID [1] 252206 0
Is Ketofol safe and better sedation for TOE cardioversion?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 4649 0
Condition category
Condition code
Anaesthesiology 4953 4953 0 0
Anaesthetics
Cardiovascular 237225 237225 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Propofol and ketamine for sedation for Tranoesophageal Echocardiography followed by Cardioversion (TOE cardioversion).
1/ propofol 200mg and ketamine 40mg will be combined in the same syringe (propofol 10mg/ml, ketamine 2mg/ml). After 25mcg of fentanyl intravenously (IV) 2-4mL boluses of the drug combination will be administered intravenously (IV) every 15-30 seconds according to clinical response. Treatment in this method will be continued until sucessful cardioversion or abandoning of the procedure as decided by the treating cardiologist.
2/ Cardioversion will be external with pads placed by the cardiologist, usually antero-posterior (AP) positioning is used. A single episode of care (with number of attempts at cardioversion determined by patient response) will be studied.
Intervention code [1] 4414 0
Treatment: Drugs
Comparator / control treatment
Propofol for sedation for Tranoesophageal Echocardiography followed by Cardioversion (TOE cardioversion).
1/ propofol 200mg will be used in a 20ml syringe (propofol 10mg/ml). After 25mcg of fentanyl IV 2-4mL boluses of propofol will be administered IV every 15-30 seconds according to clinical response. Treatment in this method will be continued until sucessful cardioversion or abandoning of the procedure as decided by the treating cardiologist.
2/ Cardioversion will be external with pads placed by the cardiologist, usually AP positioning is used. A single episode of care (with number of attempts at cardioversion determined by patient response) will be studied.
Control group
Active

Outcomes
Primary outcome [1] 5800 0
Tissue tracking displacement (transthoracic echocardiographic)
Timepoint [1] 5800 0
pre-anaesthetic, post induction, post cardioversion
Secondary outcome [1] 241797 0
Hypotension measured non-invasively at least every 3 minutes
Timepoint [1] 241797 0
pre-anaesthetic, post induction, post cardioversion

Eligibility
Key inclusion criteria
Atrial fibrillation booked for TOE followed by cardioversion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergy, psychosis, planned genaral anaesthesia with intubation

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)
Recruitment in day of surgery area of patients scheduled to undergo TOE+cardioversion. Randomisation to treatment or control based on recruitment order. (list held in anaesthetic dept.)
Allocation will not be concealed from the treating anaesthetist but from the observing cardiologist and data collector (one of 4 medical students participating in project)
Sealed opaque envelopes indicating allocation will be viewed by the treating anaesthetist only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random sequence generator (web-based computerised)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4830 0
Hospital
Name [1] 4830 0
fremantle hospital,
Country [1] 4830 0
Australia
Funding source category [2] 5044 0
Self funded/Unfunded
Name [2] 5044 0
fremantle hospital (bequest - deceased estate ex-surgeon)
Country [2] 5044 0
Australia
Primary sponsor type
Hospital
Name
fremantle hospital (bequest - deceased estate ex-surgeon)
Address
alma st, Fremantle, WA, 6160
Country
Australia
Secondary sponsor category [1] 4371 0
None
Name [1] 4371 0
Address [1] 4371 0
Country [1] 4371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6889 0
Ethics committee address [1] 6889 0
Ethics committee country [1] 6889 0
Date submitted for ethics approval [1] 6889 0
14/03/2009
Approval date [1] 6889 0
Ethics approval number [1] 6889 0

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

Contacts
Principal investigator
Name 29523 0
Address 29523 0
Country 29523 0
Phone 29523 0
Fax 29523 0
Email 29523 0
Contact person for public queries
Name 12770 0
Ed O'Loughlin
Address 12770 0
fremantle hospital
Alma st, Fremantle
Western Australia
6160
Country 12770 0
Australia
Phone 12770 0
+61 8 9431 3333
Fax 12770 0
Email 12770 0
[email protected]
Contact person for scientific queries
Name 3698 0
Ed O'Loughlin
Address 3698 0
fremantle Hospital
Alma St, Fremantle
WA 6160
Country 3698 0
Australia
Phone 3698 0
+61 8 9431 3333
Fax 3698 0
Email 3698 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.