Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000361909
Ethics application status
Approved
Date submitted
6/04/2011
Date registered
7/04/2011
Date last updated
7/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the anaesthetic drug propofol affect the blood levels of the endogenous cannabis-like substance anandamide?
Scientific title
Effect of propofol on the peri-operative plasma level of the endogenous cannabinoid anandamide in patients undergoing minor elective surgery
Secondary ID [1] 259945 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peri-operative Anandamide Plasma Levels 265564 0
Condition category
Condition code
Anaesthesiology 265712 265712 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maintenance of anaesthesia with intravenous propofol (target controlled infusion as clinically required: 4-6 mcg/ml)/fentanyl (as clinically required)
Intervention code [1] 264357 0
Treatment: Drugs
Comparator / control treatment
Induction of anaesthesia with intravenous Thiopentone (3-5 mg/kg) and maintenance with sevoflurane (0.8-1.2 MAC)/fentanyl (as clinically required)
Control group
Active

Outcomes
Primary outcome [1] 266476 0
Anandamide Plasma levels
Timepoint [1] 266476 0
T0: Baseline (pre-operatively)
T1: 15 minutes after induction of anaesthesia
T2: 5 minutes after cessation of sevoflurane or propofol
T3: 25 minutes after T2
T4: 55 minutes after T2
Secondary outcome [1] 273850 0
nil
Timepoint [1] 273850 0
nil

Eligibility
Key inclusion criteria
patients scheduled for minor non-emergency surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 yrs and > 65 yrs, ASA physical status > 2 (= significant comorbidity), history of chronic pain, a contraindication for any of the used drugs, and the incapacity to consent.

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)
Patients are randomised into one of two groups: Propofol or Sevo. This is done via opening a sealed envelope directly prior to surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
30 sealed envelopes containing information about the group allocation (either PROP or SEVO, n=15 each).
Envelopes randomly mixed after sealing and numbered from 1-30
Envelopes drwan for randomisation in order of patients consented (e.g. patient 1 = envelope 1).
Seal broken directly prior to surgery.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2011
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] 264827 0
Self funded/Unfunded
Name [1] 264827 0
Country [1] 264827 0
Primary sponsor type
Individual
Name
Thomas Ledowski
Address
Royal Perth Hospital
Dept. of Anaesthesia
Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 263934 0
None
Name [1] 263934 0
Address [1] 263934 0
Country [1] 263934 0
Other collaborator category [1] 251931 0
Individual
Name [1] 251931 0
Prof. Kevin Croft
Address [1] 251931 0
Level 4 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country [1] 251931 0
Australia
Other collaborator category [2] 251932 0
Individual
Name [2] 251932 0
Prof. Trevor Mori
Address [2] 251932 0
Level 4 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country [2] 251932 0
Australia
Other collaborator category [3] 251933 0
Individual
Name [3] 251933 0
Prof. Anne Barden
Address [3] 251933 0
Level 4 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country [3] 251933 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266791 0
EC of the Royal Perth Hospital
Ethics committee address [1] 266791 0
Colonial House
Royal Perth Hospital
Wellington Street
Perth WA 6000
Ethics committee country [1] 266791 0
Australia
Date submitted for ethics approval [1] 266791 0
01/10/2010
Approval date [1] 266791 0
14/02/2011
Ethics approval number [1] 266791 0
EC 2010/096

Summary
Brief summary
Anandamide is a body-own (endogenous) cannabis-like substance that is significantly involved in our response to stress, but also affects mood and has anti-nausea effects.
In the proposed project we will investigate the effect of the drugs propofol and sevoflurane (two of the most commonly used anaesthetic agents) on the blood concentration of the cannabis-like substance anandamide in 30 patients having an operation at Royal Perth Hospital.
In this trial, patients (15 each) will either receive an anaesthetic with propofol or with sevoflurane and we will measure the blood levels of anandamide by drawing blood (2x5ml) from a venous cannula anyway used to give the anaesthetic at 5 time points.
Results of this project will help us to understand significant positive side effects of propofol, such as its anti-nausea properties.
Trial website
nil
Trial related presentations / publications
not yet published
Public notes

Contacts
Principal investigator
Name 32449 0
Address 32449 0
Country 32449 0
Phone 32449 0
Fax 32449 0
Email 32449 0
Contact person for public queries
Name 15696 0
Thomas Ledowski
Address 15696 0
Royal Perth Hospital
Dept. of Anaesthesia
Wellington Street
Perth WA 6000
Country 15696 0
Australia
Phone 15696 0
0061 8 9224 1037
Fax 15696 0
0061 8 9224 1111
Email 15696 0
[email protected]
Contact person for scientific queries
Name 6624 0
Thomas Ledowski
Address 6624 0
Royal Perth Hospital
Dept. of Anaesthesia
Wellington Street
Perth WA 6000
Country 6624 0
Australia
Phone 6624 0
0061 8 9224 1037
Fax 6624 0
Email 6624 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.