Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000118606
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
10/08/2005
Date last updated
10/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictive value and reaction times of skin conductivity versus bispectral index for assessment of awakening after total intravenous anaesthesia
Scientific title
Predictive value and reaction times of skin conductivity versus bispectral index for assessment of awakening after total intravenous anaesthesia
Universal Trial Number (UTN)
Trial acronym
SCA TIVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin conductance and bispectral index 206 0
Condition category
Condition code
Anaesthesiology 230 230 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Skin conductance and bispectral index monitoring during anaesthesia.
Intervention code [1] 128 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 277 0
Reaction times of skin conductivity versus bispectral index for assessment of awakening after total intravenous anaesthesia
Timepoint [1] 277 0
Secondary outcome [1] 621 0
Correlation of skin conductance and bispectral index with clinical signs of awaking after anaesthesia.
Timepoint [1] 621 0

Eligibility
Key inclusion criteria
Patients ASA physical status 1-3, body weight within normal limits (+/- 15 % of normal body weight (height minus 100 in kg)).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known dependency on alcohol or nicotine; epileptic; peripheral vascular disease or autonomic neuropathy potentially involving the hand; medication known to interfere with normal responses to the sympathetic nervous system (e.g. beta-blockers, atropine); pacemaker.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 291 0
Commercial sector/Industry
Name [1] 291 0
MED Storm Innovations
Country [1] 291 0
Norway
Primary sponsor type
Hospital
Name
Departmental funding Dept. of Anaesthesia Royal Perth Hospital
Address
Country
Australia
Secondary sponsor category [1] 222 0
None
Name [1] 222 0
n/a
Address [1] 222 0
Country [1] 222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1146 0
Royal Perth Hospital
Ethics committee address [1] 1146 0
Ethics committee country [1] 1146 0
Australia
Date submitted for ethics approval [1] 1146 0
Approval date [1] 1146 0
Ethics approval number [1] 1146 0

Summary
Brief summary
Comparison of skin conductance and bispectral index monitoring for prediction of postoperative awaking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35788 0
Address 35788 0
Country 35788 0
Phone 35788 0
Fax 35788 0
Email 35788 0
Contact person for public queries
Name 9317 0
Thomas Ledowski
Address 9317 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 9317 0
Australia
Phone 9317 0
+61 8 92242797
Fax 9317 0
+61 8 92241111
Email 9317 0
[email protected]
Contact person for scientific queries
Name 245 0
Thomas Ledowski
Address 245 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 245 0
Australia
Phone 245 0
+61 8 92242797
Fax 245 0
+61 8 92241111
Email 245 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.