Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000129684
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
11/08/2005
Date last updated
30/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The correlation between magnetic resonance imaging measured lumbosacral cerebrospinal fluid volume and the sensory block height obtained following spinal anaesthesia in elderly patients
Scientific title
The correlation between magnetic resonance imaging measured lumbosacral cerebrospinal fluid volume and the sensory block height obtained following spinal anaesthesia in elderly patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 217 0
Condition category
Condition code
Anaesthesiology 244 244 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic resonance imaging preoperatively
Intervention code [1] 174 0
Diagnosis / Prognosis
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290 0
MRI measurement of CSF volume
Timepoint [1] 290 0
preoperatively
Secondary outcome [1] 647 0
Sensory block height under spinal anaesthesia.
Timepoint [1] 647 0
prior to surgery

Eligibility
Key inclusion criteria
Undergoing transurethral resection of prostate under spinal anaesthesia, BMI <30
Minimum age
60 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac pacemaker, artificial heart valve, brain aneurysm clips, spinal electrodes, cochlear implant, spinal electrodes.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
convenience sample
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2005
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] 303 0
Self funded/Unfunded
Name [1] 303 0
Country [1] 303 0
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington St Perth WA 6000
Country
Australia
Secondary sponsor category [1] 235 0
None
Name [1] 235 0
NIL
Address [1] 235 0
Country [1] 235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1173 0
Royal Perth Hospital
Ethics committee address [1] 1173 0
Wellington St, Perth WA 6000
Ethics committee country [1] 1173 0
Australia
Date submitted for ethics approval [1] 1173 0
Approval date [1] 1173 0
15/05/2005
Ethics approval number [1] 1173 0

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

Contacts
Principal investigator
Name 35837 0
Address 35837 0
Country 35837 0
Phone 35837 0
Fax 35837 0
Email 35837 0
Contact person for public queries
Name 9363 0
John Martyr
Address 9363 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9363 0
Australia
Phone 9363 0
+61 8 92243104
Fax 9363 0
Email 9363 0
[email protected]
Contact person for scientific queries
Name 291 0
Shauna Fatovich
Address 291 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 291 0
Australia
Phone 291 0
+61 8 92241036
Fax 291 0
Email 291 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.