Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000098639
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
8/08/2005
Date last updated
8/08/2005
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 balanced anaesthesia
Scientific title
Predictive value and reaction times of skin conductivity versus bispectral index for assessment of awakening after balanced anaesthesia
Universal Trial Number (UTN)
Trial acronym
SCA BAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bispectral index/skin conductance 179 0
Condition category
Condition code
Skin 202 202 0 0
Normal skin development and function
Anaesthesiology 203 203 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intraoperative monitoring of bispectral index/skin conductance.
Intervention code [1] 127 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 242 0
Reaction times of bispectral index vs. skin conductance regarding postoperative awaking
Timepoint [1] 242 0
Secondary outcome [1] 549 0
Correlation of bispectral index.
Timepoint [1] 549 0
Secondary outcome [2] 550 0
Skin conductance with clinical signs of awareness.
Timepoint [2] 550 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; on 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
1/09/2005
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] 257 0
Commercial sector/Industry
Name [1] 257 0
MED Storm Innovations
Country [1] 257 0
Norway
Primary sponsor type
Hospital
Name
Departmental funding Dept. of Anaesthesia Royal Perth Hospital
Address
Country
Australia
Secondary sponsor category [1] 196 0
None
Name [1] 196 0
n/a
Address [1] 196 0
Country [1] 196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1085 0
Royal Perth Hospital
Ethics committee address [1] 1085 0
Ethics committee country [1] 1085 0
Australia
Date submitted for ethics approval [1] 1085 0
Approval date [1] 1085 0
Ethics approval number [1] 1085 0

Summary
Brief summary
Two monitoring devices (Skin conductance and bispectral index) are tested regarding their predictive value and reaction times for postoperative awaking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35414 0
Address 35414 0
Country 35414 0
Phone 35414 0
Fax 35414 0
Email 35414 0
Contact person for public queries
Name 9316 0
Thomas Ledowski
Address 9316 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9316 0
Australia
Phone 9316 0
+61 8 92242797
Fax 9316 0
+61 8 92241111
Email 9316 0
thomas.ledowski@health.wa.gov.au
Contact person for scientific queries
Name 244 0
Thomas Ledowski
Address 244 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 244 0
Australia
Phone 244 0
+61 8 92242797
Fax 244 0
+61 8 92241111
Email 244 0
thomas.ledowski@health.wa.gov.au

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.