Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000385943
Ethics application status
Approved
Date submitted
12/04/2011
Date registered
13/04/2011
Date last updated
14/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Propofol on Ability to Drive
Scientific title
Estimation of the simulated driving ability of post-surgical patients with varying Propofol plasma concentrations
Secondary ID [1] 259983 0
Nil
Universal Trial Number (UTN)
U1111-1120-6981
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driving impairment by Propofol 265607 0
Condition category
Condition code
Anaesthesiology 265754 265754 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of Propofol via intravenous infusion
a) The dose will be titrated to achieve an estimated plasma concentration of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 mg/mL in stepwise progression
b) the infusion will be continuous and will not exceed 30 minutes
Intervention code [1] 264396 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266512 0
Driving ability - Assessed using the CyberLITE driving simulator which will be contained within the surgical suites. Patients will, at basleine and the varying plasma propofol concentrations will perform a short course on the simulator.
Timepoint [1] 266512 0
The primary outcome is assessed at Baseline and every 5 minutes when the plasma propofol concetration will be increased to 0.5, 1.0, 1.5, 2.0, 2.5, 3.0.
Secondary outcome [1] 273932 0
Nil
Timepoint [1] 273932 0
Nil

Eligibility
Key inclusion criteria
Patients undergoing day-case surgery at Monash Medical Centre;
Patients that are expected to be receiving a Propofol based anaesthetic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Below 18 years of age;
Insufficient English comprehension to understand consent form;
Too ill to participate as judged by the Prinipal Investigator;
Patient refusal;
Known allergy to Propofol;
Absent limb or limbs;
Documented cerebrovascular accident;
Documented intra-cranial space occupying lesion;
No current driver’s licence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Source of participants – patients will be sourced at the Preadmission Clinic and provided with literature discussing participation in the study.

No randomisation will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264858 0
Hospital
Name [1] 264858 0
Southern Health
Country [1] 264858 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 263957 0
None
Name [1] 263957 0
Address [1] 263957 0
Country [1] 263957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266821 0
Southern Health HREC
Ethics committee address [1] 266821 0
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [1] 266821 0
Australia
Date submitted for ethics approval [1] 266821 0
18/04/2011
Approval date [1] 266821 0
27/05/2011
Ethics approval number [1] 266821 0
11130A

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

Contacts
Principal investigator
Name 32474 0
Address 32474 0
Country 32474 0
Phone 32474 0
Fax 32474 0
Email 32474 0
Contact person for public queries
Name 15721 0
Sud Agarwal
Address 15721 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country 15721 0
Australia
Phone 15721 0
+61395956666
Fax 15721 0
Email 15721 0
[email protected]
Contact person for scientific queries
Name 6649 0
Sud Agarwal
Address 6649 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country 6649 0
Australia
Phone 6649 0
+61395956666
Fax 6649 0
Email 6649 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
EmbaseDriving impairment due to propofol at effect-site concentrations relevant after short propofol-only sedation.2016https://dx.doi.org/10.1177/0310057x1604400602
N.B. These documents automatically identified may not have been verified by the study sponsor.