Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000025033
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
8/01/2010
Date last updated
8/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of propofol on emergence delirium in children after sevoflurane anaesthesia
Scientific title
The effect of propofol on emergence delirium in children after sevoflurane anaesthesia for magnetic resonance imaging (MRI). A randomized controlled trial.
Secondary ID [1] 1244 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post anaesthetic emergence delirium in children 256455 0
Condition category
Condition code
Anaesthesiology 256624 256624 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We wish to examine whether administration of intravenous propofol 3mg/kg over 3 minutes at the end of a sevoflurane anaesthetic can reduce the incidence of emergence delirium in children.
Intervention code [1] 255745 0
Treatment: Drugs
Comparator / control treatment
Standard treatment where no propofol is administered. The patient would breathe spontaneously until they have breathed off sufficient sevoflurane for them to wake. The patient will then either wake up in the induction room next to the MRI scanner or be transfered to theatre recovery prior to waking. This will be at the discretion of the individual anaesthetist.
Control group
Active

Outcomes
Primary outcome [1] 257514 0
The incidence of emergence delirium. This is to be assessed by using the Paediatric Anaesthesia Emergence Delirium (PAED) Scale and Watcha behaviour score.
Timepoint [1] 257514 0
From arrival in theatre recovery until the patient is fully awake.
Secondary outcome [1] 262735 0
Time from arrival in theatre recovery to discharge from recovery.
Timepoint [1] 262735 0
Time of discharge from recovery.
Secondary outcome [2] 262736 0
Time from arrival in theatre recovery to hospital discharge.
Timepoint [2] 262736 0
Time of discharge from hospital.

Eligibility
Key inclusion criteria
Children listed for Magnetic Resonance Imaging under general anaesthesia.
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to propofol or egg product.
History of Malignant Hyperpyrexia.
Any child due to also undergo a painful procedure or one requiring pupil dilatation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients listed for MRI under General Anaesthesia (GA) are to be invited to participate providing they meet the inclusion criteria. Once enrolled a sequentially numbered opaque sealed envelope is to be placed in the notes and the anaesthetist informed of the patients inclusion. The pack envelope contains the treatment group information. The pack is to be opened only once the patient has entered the MR scanner and neither the recovery nurse or the assessor will be aware of the randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence will allocate treatment or control group information to sequentially numbered opaque packs. The packs will be filled by an individual with no other involvement in the trial process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256220 0
Hospital
Name [1] 256220 0
Women's and Children's Hospital
Country [1] 256220 0
Australia
Funding source category [2] 256224 0
Self funded/Unfunded
Name [2] 256224 0
Country [2] 256224 0
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
King William Road
North Adelaide
South Australia
5006
Country
Australia
Secondary sponsor category [1] 251557 0
Government body
Name [1] 251557 0
South Australian Department of Health
Address [1] 251557 0
Insurance Services Unit,
Department of Health,
PO Box 287
Rundle Mall
Adelaide SA 5000
Country [1] 251557 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258319 0
Children's Youth and Women's Health Service Research Ethics Committee
Ethics committee address [1] 258319 0
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia 5006
Ethics committee country [1] 258319 0
Australia
Date submitted for ethics approval [1] 258319 0
Approval date [1] 258319 0
17/12/2009
Ethics approval number [1] 258319 0
REC2216/10/12

Summary
Brief summary
After anaesthesia children frquently become irritable and distressed. This is termed Emergence Delirium (ED). Sometimes this can lead to intravenous lines and surgical drains becoming dislodged. The child rarely remember this period and it rarely has any longterm consequences. A number of studies have suggested that a commonly used anaesthetic drug called propofol can be used to reduce the chance of this happening. We plan to administer a dose of propofol at the end of an anaesthetic to see whether it will reduce the rate of ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30649 0
Address 30649 0
Country 30649 0
Phone 30649 0
Fax 30649 0
Email 30649 0
Contact person for public queries
Name 13896 0
Dr Allan Cyna
Address 13896 0
Department of Women’s Anaesthesia
Women’s and Children’s Hospital
72 King William Road
North Adelaide
SA 5006
Country 13896 0
Australia
Phone 13896 0
+61 8 81617630
Fax 13896 0
Email 13896 0
[email protected]
Contact person for scientific queries
Name 4824 0
Dr Allan Cyna
Address 4824 0
Department of Women’s Anaesthesia
Women’s and Children’s Hospital
72 King William Road
North Adelaide
SA 5006
Country 4824 0
Australia
Phone 4824 0
+61 8 81617630
Fax 4824 0
Email 4824 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
SourceTitleYear of PublicationDOI
EmbaseTransition to propofol after sevoflurane anesthesia to prevent emergence agitation: A randomized controlled trial.2015https://dx.doi.org/10.1111/pan.12617
N.B. These documents automatically identified may not have been verified by the study sponsor.