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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00455026




Registration number
NCT00455026
Ethics application status
Date submitted
1/04/2007
Date registered
3/04/2007
Date last updated
30/05/2013

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
2005.236
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

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
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 EEG abnormality

- Prescription or illicit drugs known to affect the EEG

Study design
Purpose of the study
Diagnosis
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
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
Other
Name
Melbourne Health
Address
Country
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

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00455026
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00455026