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Trial registered on ANZCTR


Registration number
ACTRN12611000978965
Ethics application status
Approved
Date submitted
2/09/2011
Date registered
14/09/2011
Date last updated
12/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of the Brain Anaesthesia Response (BAR) Monitoring System during Anaesthesia for Cardiac Surgery: a Double-Blinded, Randomised, Controlled Trial using Two Different Doses of Fentanyl.
Scientific title
Validation of the Brain Anaesthesia Response (BAR) Monitoring System during Anaesthesia for Cardiac Surgery: a Double-Blinded, Randomised, Controlled Trial using Two Different Doses of Fentanyl.
Secondary ID [1] 262978 0
Nil
Universal Trial Number (UTN)
U1111-1124-2523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depth of anaesthesia 270700 0
Condition category
Condition code
Anaesthesiology 270874 270874 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fentanyl moderate dose 24mcg/kg IV on induction
Intervention code [1] 269320 0
Treatment: Drugs
Comparator / control treatment
Fentanyl low dose 12mcg/kg IV on induction
Control group
Dose comparison

Outcomes
Primary outcome [1] 279556 0
The Brain Anaesthesia Response (BAR) monitor system is designed to non-invasively monitor brain function in response to anaesthetic and sedative agents. The system consists of a terminal, a data acquisition module (DAM) and a disposable electrical sensor array. Electroencephalography (EEG) signals are collected using the sensor which is applied to the patients? forehead. The signals are processed to calculate two BAR indices, Cortical State (CS) and Cortical Input (CI). The displayed indices are designed to assist the anaesthetist to estimate the levels of consciousness and analgesia of a patient during general anaesthesia. This study is designed to detect varying levels of anaesthetic agents in an operating room environment where the presence of multiple sources of artifacts are known to complicate the EEG assessment of anaesthetic action.
Timepoint [1] 279556 0
Induction to pre cardiopulmonary bypass for on pump coronary artery bypass surgery.
Induction to pericaridal dissection for off pump coronary artery bypass surgery
Secondary outcome [1] 287898 0
Nil
Timepoint [1] 287898 0
Nil

Eligibility
Key inclusion criteria
Males and females aged 18 to 80 years undergoing elective first-time coronary artery bypass graft surgery with American Society of Anaesthesiologist Classification III or IV
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability Epilepsy or other conditions which may affect the EEG History of prescription or illicit drug use known to affect the EEG Body Weight > 120 kg Allergy to trial medications Uncontrolled hyper- or hypotension, congestive cardiac failure or an ejection fraction of < 25% Permanent or temporary pacemaker in situ

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who meet the eligibility criteria will be approached and written informed consent will be obtained. This will occur in the pre-admission clinic or on the ward the day before surgery. Randomisation results will be concealed in envelopes that will be allocated squentially to consented patients. The envelope will be opended and study drug drawn up by doctor who in not involved in the study or the intra-operative care of the patient
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be determined using a computer-generated list using the program PC-Plan. The randomisation allocation will be sealed in an envelope by a person who is not a member of the research team or who will be invovled in care of any intra-operative cardiac patient.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269783 0
Commercial sector/Industry
Name [1] 269783 0
Cortical Dynamics
Address [1] 269783 0
PO Box 317 North Perth 6906 WA
Country [1] 269783 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cortical Dynamics
Address
PO Box 317 North Perth 6906 WA
Country
Australia
Secondary sponsor category [1] 268823 0
None
Name [1] 268823 0
Address [1] 268823 0
Country [1] 268823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271742 0
St Vincent's Health
Ethics committee address [1] 271742 0
PO Box 2900
Fitzroy 3065 VIC
Ethics committee country [1] 271742 0
Australia
Date submitted for ethics approval [1] 271742 0
26/09/2011
Approval date [1] 271742 0
08/11/2011
Ethics approval number [1] 271742 0
HREC-D 125/11

Summary
Brief summary
The Brain Anaesthesia Response (BAR) monitor system is designed to non-invasively monitor brain function in response to anaesthetic and sedative agents. Electroencephalography (EEG) signals are collected using the sensor which is applied to the patients’ forehead. The signals are processed to calculate two BAR indices, Cortical State (CS) and Cortical Input (CI). The displayed indices are designed to assist the anaesthetist to estimate the levels of consciousness and analgesia of a patient during general anaesthesia. The study is designed to investigate whether the BAR indices recorded in the operating room environment can distinguish between two groups of patients anaesthetised with either a low or a moderate dose of fentanyl and show clinically meaningful correlations with levels of hypnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33106 0
Address 33106 0
Country 33106 0
Phone 33106 0
Fax 33106 0
Email 33106 0
Contact person for public queries
Name 16353 0
Ms Simone Said
Address 16353 0
Deptartment of Anaesthesia
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 16353 0
Australia
Phone 16353 0
61 3 9288 4245
Fax 16353 0
61 3 9288 4255
Email 16353 0
simone.said@svhm.org.au
Contact person for scientific queries
Name 7281 0
Dr Des McGlade
Address 7281 0
Deptartment of Anaesthesia
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 7281 0
Australia
Phone 7281 0
61 3 9288 4253
Fax 7281 0
61 3 9288 4255
Email 7281 0
desmond.mcglade@svhm.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary