Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000474257
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
3/04/2018
Date last updated
3/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing motor and cognitive function pre and post propofol only anaesthesia for endoscopic procedures.
Scientific title
Assessing motor and cognitive function pre and post propofol only anaesthesia for endoscopic procedures using the SART and SOPT.
Secondary ID [1] 294425 0
Nil Known
Universal Trial Number (UTN)
U1111-1211-2916
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Propofol only sedational anaesthesia in endoscopic procedures 307172 0
Condition category
Condition code
Anaesthesiology 306288 306288 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients receiving propofol only anaesthesia for endoscopic procedures are administered two computer programs called the "self ordered pointing test" (SOPT) and the "sustained attention to response task" (SART). These tests were administered 30 minutes prior to the patients procedure and again, 1 hour post emergence from the patients procedure and patients were observed for an estimated 1.5 hours in total from the first to last assessment.

In the SOPT test, the participant is presented number of images and she/he is asked to pick one. On the next screen the order of the images is scrambled and the subject is asked to pick a different image amongst the number of images which were presented to a participant on the previous screen. This repeats until all images are selected. This test measures working memory, verbal learning, visuospatial ability, and select aspects of executive functioning.

The SART test is a computer-based task designed to measure a person's ability to withhold responses to infrequent and unpredictable stimuli during a period of rapid and rhythmic responding to frequent stimuli. The participant was flashed a sequence of disordered numbers between 1-9 and was asked to press the space bar in response to being flashed the number 3.

The SART and SOPT have been studied heavily in the past with subjects exposed to alcohol and validated to a BAL of <0.05.
Intervention code [1] 300720 0
Not applicable
Comparator / control treatment
A control arm completed the SART and SOPT test. This group only consisted of healthy volunteers who were exposed to no propofol and underwent no endoscopic intervention. These volunteers completed the tests at a interval of one hour. We aimed to mitigate any potential learning bias with the results from this arm of the study.
Control group
Active

Outcomes
Primary outcome [1] 305291 0
To demonstrate whether there is or isn't a significant effect of propofol only anaesthesia on cognitive function at one hour post administration of propofol in the endoscopy setting.
Timepoint [1] 305291 0
Patient were recruited on presentation to the endoscopic department
Approximately 30 mins prior to their procedure, they conducted both the SART and SOPT tests
Patients were reassessed with the SART and SOPT one hour after presenting to the recovery room post procedure.


Secondary outcome [1] 344754 0
NA
Timepoint [1] 344754 0
NA

Eligibility
Key inclusion criteria
Any ages welcomed >18y
Patients must have received propofol only anaesthesia for endoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior history of dementia or cognitive impairment
Recent use of alcohol/benzodiazepines
Non English speakers

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
305 patients to be enrolled in both propofol and control group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/05/2016
Date of last participant enrolment
Anticipated
Actual
19/01/2018
Date of last data collection
Anticipated
Actual
19/01/2018
Sample size
Target
610
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10451 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 22160 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299056 0
Hospital
Name [1] 299056 0
St Vincent's Private Hospital
Country [1] 299056 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Darlinghurst
Address
390 Victoria St,
Darlinghurst.
NSW, Australia, 2010
Country
Australia
Secondary sponsor category [1] 298291 0
None
Name [1] 298291 0
Address [1] 298291 0
Country [1] 298291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299989 0
St Vincent's Hospital Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 299989 0
390 Victoria St,
Darlinghurst,
NSW, Australia, 2010
Ethics committee country [1] 299989 0
Australia
Date submitted for ethics approval [1] 299989 0
27/10/2015
Approval date [1] 299989 0
17/12/2015
Ethics approval number [1] 299989 0
15/238

Summary
Brief summary
There has been an increase in the number of discharges against medical advice for endoscopic procedures in recent times and given this, patients could be at significant risk when discharging unsupervised from the clinical environment. As many patients now receive propofol as the sole agent for sedational anaesthesia for endoscopic procedures, we decided to conduct a study that assesses the cognitive and motor function of patients before and after propofol only anaesthesia in this clinical setting. We did this by using two computer tests called the SART and SOPT, which are validated to a BAL of 0.05 and were completed by patients prior to and again one hour after their procedure. We also conduced the same battery of tests on volunteers not receiving propofol to assess for any learning bias obtained by participants completing the test at one hour intervals. From this study, we aim to determine the level of cognitive impairment 1 hour post propofol only anaesthesia for endoscopic procedures, if any, which may help with discharge planning for patients in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82182 0
Dr Jenny Stevens
Address 82182 0
St Vincent's Anaesthetic Department
St Vincent's Hospital
390 Victoria St,
Darlinghurst,
NSW, Australia, 2010
Country 82182 0
Australia
Phone 82182 0
+61 2 83821111
Fax 82182 0
Email 82182 0
[email protected]
Contact person for public queries
Name 82183 0
James Kelly
Address 82183 0
St Vincent's Hospital
390 Victoria St,
Darlinghurst,
NSW, Australia, 2010
Country 82183 0
Australia
Phone 82183 0
+61 2 83821111
Fax 82183 0
Email 82183 0
[email protected]
Contact person for scientific queries
Name 82184 0
Drew Heffernan
Address 82184 0
St Vincent's Anaesthetic Department
St Vincent's Hospital
390 Victoria St,
Darlinghurst,
NSW, Australia, 2010
Country 82184 0
Australia
Phone 82184 0
+61 2 83821111
Fax 82184 0
Email 82184 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

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