Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12605000221651
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
26/08/2005
Date last updated
16/10/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Propofol induction in cannabis using patients
Query!
Scientific title
Dose of Propofol for induction of general anaesthesia in cannabis using patients
Query!
Secondary ID [1]
287683
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PICUP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anaesthesia
304
0
Query!
Condition category
Condition code
Anaesthesiology
347
347
0
0
Query!
Other anaesthesiology
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The dose of propofol required to induce general anaesthesia will be compared in cohorts of patients who use cannabis regularly and those who do not use it at all.
The duration of the intervention is 90 seconds, the time required to reach or not reach primary endpoint of unconsciousness.
Query!
Intervention code [1]
169
0
None
Query!
Comparator / control treatment
Non-cannabis users
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
402
0
The successful insertion of a laryngeal mask after induction of anaesthesia
Query!
Assessment method [1]
402
0
Query!
Timepoint [1]
402
0
60 seconds post-successful induction of anaesthesia
Query!
Secondary outcome [1]
874
0
The dose of intravenous propofol required to achieve a bispectral index value of less than 60.
Query!
Assessment method [1]
874
0
Query!
Timepoint [1]
874
0
post-successful induction of anaesthesia
Query!
Eligibility
Key inclusion criteria
LMA anaesthesia, ASA 1-2.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Weight >100kgs, cardiovascular disease, use of opiod,cocaine or amphetamines,benzodiazepine & SSRI use, allergy to propofol,alcohol abuse, anti retro-viral therapy, unstable pre-induction BIS value.
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to one of 5 groups, in blocks within each of the two cohorts of 30. This was achieved by using a computer software randomisation sequence.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/01/2005
Query!
Actual
1/07/2005
Query!
Date of last participant enrolment
Anticipated
31/12/2007
Query!
Actual
31/12/2007
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
407
0
Self funded/Unfunded
Query!
Name [1]
407
0
Query!
Address [1]
407
0
Query!
Country [1]
407
0
Query!
Primary sponsor type
Individual
Query!
Name
Dr Per Flisberg
Query!
Address
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington St Perth WA 6000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
330
0
None
Query!
Name [1]
330
0
NIL
Query!
Address [1]
330
0
Query!
Country [1]
330
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
293701
0
Royal Perth Hospital
Query!
Ethics committee address [1]
293701
0
Royal Perth Hospital Wellington St Perth WA 6000
Query!
Ethics committee country [1]
293701
0
Australia
Query!
Date submitted for ethics approval [1]
293701
0
31/10/2004
Query!
Approval date [1]
293701
0
01/04/2005
Query!
Ethics approval number [1]
293701
0
NA
Query!
Summary
Brief summary
Trial completed and published 2009
Flisberg P, Paech MJ, Shah T, Ledowski T, Kurowski I, Parsons R. Induction dose of propofgol in patients using cannabis. Euro J Anaesthesiol 2009;26:192-5
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
35954
0
Dr Per Flisberg
Query!
Address
35954
0
Department of Anaesthesia and Intensive Care, Lund University Hospital, Lund
Query!
Country
35954
0
Sweden
Query!
Phone
35954
0
+48 46 17 19 49
Query!
Fax
35954
0
Query!
Email
35954
0
[email protected]
Query!
Contact person for public queries
Name
9358
0
Prof Michael Paech
Query!
Address
9358
0
Department of Anaesthesia & Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Query!
Country
9358
0
Australia
Query!
Phone
9358
0
+61 8 92241036
Query!
Fax
9358
0
Query!
Email
9358
0
[email protected]
Query!
Contact person for scientific queries
Name
286
0
Mrs Shauna Fatovich
Query!
Address
286
0
Department of Anaesthesia & Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Query!
Country
286
0
Australia
Query!
Phone
286
0
+61 8 92241036
Query!
Fax
286
0
Query!
Email
286
0
[email protected]
Query!
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.
Download to PDF