Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000407493
Ethics application status
Approved
Date submitted
3/08/2007
Date registered
7/08/2007
Date last updated
7/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skin Conductance as a means to predict hypotension following spinal anaesthesia
Scientific title
Skin Conductance as a means to predict hypotension following spinal anaesthesia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension after spinal anaesthesia 2216 0
Condition category
Condition code
Anaesthesiology 2307 2307 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of the relationship between Skin Conductance prior to spinal anaesthesia and the severity of hypotension following spinal anaesthesia within a study period of 15 minutes after spinal anaesthesia
Intervention code [1] 1927 0
Early detection / Screening
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 3202 0
Correlation between Skin Conductance and Hypotension following spinal anaesthesia.
Timepoint [1] 3202 0
For this purpose, the lowest blood pressure reading within 15 minutes after spinal anaesthesia is compared to the pre-spinal baseline value.
Secondary outcome [1] 5342 0
Sensitivity and specificity of Skin conductance values to predict hypotension.
Timepoint [1] 5342 0
For this, a pre-spinal baseline reading of Skin conductance variables and blood pressure are obtained. This reading is than compared with the lowest blood pressure reading up to 15 minutes after spinal anaesthesia.

Eligibility
Key inclusion criteria
Spinal anaesthesia
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 60, peripheral neuropathy, drugs affecting sympathetic tone

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2473 0
Hospital
Name [1] 2473 0
Department of Anaesthesia Research Fund
Royal Perth Hospital
Country [1] 2473 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Thomas Ledwoski
Address
Country
Secondary sponsor category [1] 2246 0
None
Name [1] 2246 0
n/a
Address [1] 2246 0
Country [1] 2246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4350 0
Royal Perth Hospital
Ethics committee address [1] 4350 0
WA
Ethics committee country [1] 4350 0
Australia
Date submitted for ethics approval [1] 4350 0
Approval date [1] 4350 0
Ethics approval number [1] 4350 0
EC 2006/107

Summary
Brief summary
Hypotension after spinal anaesthesia (SA) is common, especially in the elderly. It has been shown innprevious studies, that a high sympathetic tone correlates with a steeper drop in blood pressure after SA. AS skin conductance has been identified to correlate well with sympathetic tone, idea of this trial was to investigate a potential predictive value of skin conductance readings prio to SA for identification of patients likely to show hypotension after SA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27741 0
Address 27741 0
Country 27741 0
Phone 27741 0
Fax 27741 0
Email 27741 0
Contact person for public queries
Name 11116 0
A\Prof Thomas Ledowski
Address 11116 0
Associate Professor Thomas Ledowski
University of Western Australia
Anaesthesiology Unit
Royal Perth Hospital
MRF Building Level 2
GPO Box X2213
Perth WA 6847
Country 11116 0
Australia
Phone 11116 0
Tel: 0061-(0)8-92240210
Fax 11116 0
Fax: 0061-(0)8-92240279
Email 11116 0
[email protected]
Contact person for scientific queries
Name 2044 0
A\Prof. Thomas Ledowski
Address 2044 0
Associate Professor Thomas Ledowski
University of Western Australia
Anaesthesiology Unit
Royal Perth Hospital
MRF Building Level 2
GPO Box X2213
Perth WA 6847
Country 2044 0
Australia
Phone 2044 0
Tel: 0061-(0)8-92240210
Fax 2044 0
Email 2044 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
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Documents added automatically
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