Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000797875
Ethics application status
Approved
Date submitted
24/08/2011
Date registered
30/07/2012
Date last updated
30/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Peak plasma propofol levels during endoscopy
Scientific title
Peak plasma propofol levels in endoscopy patients receiving a Propofol-only anaesthetic
Secondary ID [1] 262910 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peak level of propofol in plasma during endoscopy with propofol only anaesthesia 270636 0
Condition category
Condition code
Anaesthesiology 270807 270807 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive propofol-only anaesthesia using the intermittent bolus technique.

Propofol will be administered through an intravenous cannula using the intermittent bolus technique (large loading bolus followed by small frequent boluses) which titrates dosage to adequate sedation.

The anaesthetist looking after the patient will give a propofol-only anaesthetic as per his or her usual procedure. The timing and dosage of boluses will not be stipulated by the researchers.

The loading dose is given immediately prior to commencing the endoscopy. Further boluses are given when deemed required by the anaesthetist.
Intervention code [1] 269259 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279500 0
Plasma propofol levels
Timepoint [1] 279500 0
2, 5 and 10 minutes
Secondary outcome [1] 287761 0
Nil
Timepoint [1] 287761 0
Nil

Eligibility
Key inclusion criteria
Undergoing colonoscopy or gastroscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA 3 or 4

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)
NA
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
Nil
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269726 0
Hospital
Name [1] 269726 0
Monash Medical Centre
Country [1] 269726 0
Australia
Primary sponsor type
Hospital
Name
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] 284522 0
None
Name [1] 284522 0
Address [1] 284522 0
Country [1] 284522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271694 0
Southern Health HREC
Ethics committee address [1] 271694 0
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [1] 271694 0
Australia
Date submitted for ethics approval [1] 271694 0
24/08/2011
Approval date [1] 271694 0
Ethics approval number [1] 271694 0

Summary
Brief summary
The peak plasma propofol levels of endoscopy patients (Derived mathematically from the 3 measurements) along with the context sensitive half time of propofol (determined by the length of infusion) will allow the researchers to determine the time taken for plasma propofol levels to drop below levels known to cause driving impairment and thus estimate how long it takes for patients to drive safely after receiving a propofol only anaesthetic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33069 0
Address 33069 0
Country 33069 0
Phone 33069 0
Fax 33069 0
Email 33069 0
Contact person for public queries
Name 16316 0
Sud Agarwal
Address 16316 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country 16316 0
Australia
Phone 16316 0
+61395956666
Fax 16316 0
Email 16316 0
[email protected]
Contact person for scientific queries
Name 7244 0
Sud Agarwal
Address 7244 0
Department of Anaesthesia and Perioperative Medicine
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country 7244 0
Australia
Phone 7244 0
+61395956666
Fax 7244 0
Email 7244 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.