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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Scientific title
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depth of Anaesthesia 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - remifentanil

Placebo Comparator: 1 - 0 ng/ml target effect site concentration remifentanil

Active Comparator: 2 - 2 ng/ml target concentration remifentanil

Active Comparator: 3 - 4 ng/ml target effect site concentration remifentanil

Treatment: Drugs: remifentanil
target effect site concentration during induction

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Prediction probability for prediction of anaesthetic endpoints
Timepoint [1] 0 0
During induction of anaesthesia

Key inclusion criteria
- Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for
elective surgery under general anaesthesia
Minimum age
18 Years
Maximum age
60 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Inadequate English comprehension due to a language barrier, cognitive deficit or
intellectual disability

- Epilepsy or other EEG abnormality

- Prescription or illicit drugs known to affect the EEG

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Swinburne University - Hawthorn
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3123 - Hawthorn
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Melbourne Health
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biopharmica Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect
of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our
hypothesis is that this new method will more accurately predict depth of anaesthesia than the
Bispectral Index (BIS) monitor in patients having elective surgery.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Kate Leslie, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications