Trial Review

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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
Scientific title
Dose of Propofol for induction of general anaesthesia in cannabis using patients
Secondary ID [1] 287683 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PICUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 304 0
Condition category
Condition code
Anaesthesiology 347 347 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 169 0
None
Comparator / control treatment
Non-cannabis users
Control group
Active

Outcomes
Primary outcome [1] 402 0
The successful insertion of a laryngeal mask after induction of anaesthesia
Timepoint [1] 402 0
60 seconds post-successful induction of anaesthesia
Secondary outcome [1] 874 0
The dose of intravenous propofol required to achieve a bispectral index value of less than 60.
Timepoint [1] 874 0
post-successful induction of anaesthesia

Eligibility
Key inclusion criteria
LMA anaesthesia, ASA 1-2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
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.
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
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
1/07/2005
Date of last participant enrolment
Anticipated
31/12/2007
Actual
31/12/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 407 0
Self funded/Unfunded
Name [1] 407 0
Country [1] 407 0
Primary sponsor type
Individual
Name
Dr Per Flisberg
Address
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington St Perth WA 6000
Country
Australia
Secondary sponsor category [1] 330 0
None
Name [1] 330 0
NIL
Address [1] 330 0
Country [1] 330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293701 0
Royal Perth Hospital
Ethics committee address [1] 293701 0
Ethics committee country [1] 293701 0
Australia
Date submitted for ethics approval [1] 293701 0
31/10/2004
Approval date [1] 293701 0
01/04/2005
Ethics approval number [1] 293701 0
NA

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

Contacts
Principal investigator
Name 35954 0
Dr Per Flisberg
Address 35954 0
Department of Anaesthesia and Intensive Care, Lund University Hospital, Lund
Country 35954 0
Sweden
Phone 35954 0
+48 46 17 19 49
Fax 35954 0
Email 35954 0
per.flisberg@skane.se
Contact person for public queries
Name 9358 0
Michael Paech
Address 9358 0
Department of Anaesthesia & Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9358 0
Australia
Phone 9358 0
+61 8 92241036
Fax 9358 0
Email 9358 0
michael.paech@health.wa.gov.au
Contact person for scientific queries
Name 286 0
Shauna Fatovich
Address 286 0
Department of Anaesthesia & Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 286 0
Australia
Phone 286 0
+61 8 92241036
Fax 286 0
Email 286 0
shauna.fatovich@health.wa.gov.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.