Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000634976
Ethics application status
Not yet submitted
Date submitted
14/06/2011
Date registered
22/06/2011
Date last updated
22/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery of driving ability after propofol-only sedation
Scientific title
How long after propofol only sedation can endoscopy patients drive safely (less impaired than at 0.05 BAC)?
Secondary ID [1] 262369 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driving ability after propofol only sedation for endoscopy 268073 0
Condition category
Condition code
Anaesthesiology 268218 268218 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Propofol only anaesthesia - the dose of propofol will not be controlled and will be titrated to effect by the Anaesthetist using the intermittent bolus technique.
Intervention code [1] 266762 0
Treatment: Drugs
Comparator / control treatment
No Control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 268959 0
Time taken for driving ability to return to level deemed to cause impairment less than BAC 0.05.

Studies have been completed to determine the levels of propofol that cause psychomotor impairment to the same extent as a blood alcohol concentration (BAC) of 0.05 (Grant et al 2000). The researchers are also currently carrying out a preliminary study to determine the driving ability of subjects at varying levels of propofol. This data will be compared to data (from the same simulator) already available on driving impairment at a blood alcohol concentration of 0.05.
This comparison will give the researchers a level at which driving impairment is equal or less than that of subjects with a BAC of 0.05.

Driving ability is assessed using CyberCAR Lite driving simulator.
Timepoint [1] 268959 0
0.5, 1, 2, 3 hours post cessation of anaesthesia
Secondary outcome [1] 276694 0
Effect of length of procedure and dose of propofol on rate of recovery of driving ability.

Driving ability is assessed using CyberCAR Lite driving simulator.
Timepoint [1] 276694 0
0.5, 1, 2, 3 hours post cessation of anaesthesia

Eligibility
Key inclusion criteria
Patient undergoing elective endoscopy procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Below 18 years
Patient refusal
Insufficient english to understand consent form
Patient has illness impairing ability to drive a motor vehicle (may include absent limb or limbs, documented stroke, document intracranial tumour)
Patient has multiple chronic illnesses
Known allergy to propofol or any of its consituents e.g. egg, soy
Patient taking medications known to interfere with metabolism or excretion of propofol
Documented illness that may interfere with propofol metabolism or excretion e.g. liver failure
No current driver's license
Current driving license restrictions

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



Intervention assignment
Single group
Other design features
Patients compared to own baseline
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267245 0
Hospital
Name [1] 267245 0
Monash Medical Centre
Country [1] 267245 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia - Monash Medical Centre
Address
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 266310 0
None
Name [1] 266310 0
Address [1] 266310 0
Country [1] 266310 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269236 0
Southern Health HREC
Ethics committee address [1] 269236 0
Southern Health HREC
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [1] 269236 0
Australia
Date submitted for ethics approval [1] 269236 0
23/06/2011
Approval date [1] 269236 0
Ethics approval number [1] 269236 0
Ethics committee name [2] 269273 0
Ethics committee address [2] 269273 0
Ethics committee country [2] 269273 0
Date submitted for ethics approval [2] 269273 0
23/06/2011
Approval date [2] 269273 0
Ethics approval number [2] 269273 0

Summary
Brief summary
Propofol is the trade name of the most commonly used intravenous general anaesthetic medication in Australia. This project will measure the level of impairment of driving skills after the administration of intravenous Propofol to a patient as part of an anaesthetic for gastrointestinal endoscopic procedures.
Following informed consent, the patient’s ability to drive on a video-game style driving simulator will be measured immediately prior to their surgical procedure prior to any medications being administered. This will constitute the patient’s baseline driving skill level.
The patient will then undergo their preplaned endoscopy procedure with propofol-only sedation. During the procedure, an extra cannula will be inserted in the opposite arm of the patient.
After anaesthesia has been ceased, the patient's driving skill will be re-measured on the same simulator at regular intervals (30 minutes, 1 hour, 2 hours, 3 hours post cessation of anaesthesia). each simualtion will take approximately 10 minutes.
Before each simulation, a blood sample will be taken from patients to determine the blood propofol concentration of the subjects.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 32740 0
Address 32740 0
Country 32740 0
Phone 32740 0
Fax 32740 0
Email 32740 0
Contact person for public queries
Name 15987 0
Dr Sudhanshu Agarwal
Address 15987 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country 15987 0
Australia
Phone 15987 0
+61406990536
Fax 15987 0
Email 15987 0
[email protected]
Contact person for scientific queries
Name 6915 0
Dr Sudhanshu Agarwal
Address 6915 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
Clayton
246 Clayton Rd
VIC 3168
Country 6915 0
Australia
Phone 6915 0
+61395956666
Fax 6915 0
Email 6915 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.