- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00455026
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
May 28, 2013 updated by: Melbourne Health
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.
Study Overview
Detailed Description
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited.
They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml.
Then anaesthesia will be induced with propofol.
Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured.
The raw EEG will be recorded and analysed off-line using our new method and also for BIS values.
Anaesthesia will then proceed according to the needs of the patient and the surgery.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Hawthorn, Victoria, Australia, 3123
- Swinburne University
-
Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
0 ng/ml target effect site concentration remifentanil
|
target effect site concentration during induction
Other Names:
|
Active Comparator: 2
2 ng/ml target concentration remifentanil
|
target effect site concentration during induction
Other Names:
|
Active Comparator: 3
4 ng/ml target effect site concentration remifentanil
|
target effect site concentration during induction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prediction probability for prediction of anaesthetic endpoints
Time Frame: During induction of anaesthesia
|
During induction of anaesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Leslie, MD, Melbourne Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
April 1, 2007
First Submitted That Met QC Criteria
April 2, 2007
First Posted (Estimate)
April 3, 2007
Study Record Updates
Last Update Posted (Estimate)
May 30, 2013
Last Update Submitted That Met QC Criteria
May 28, 2013
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005.236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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