Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

This study has been completed.
Sponsor:
Collaborator:
Biopharmica Limited
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00455026
First received: April 1, 2007
Last updated: May 28, 2013
Last verified: March 2007

April 1, 2007
May 28, 2013
March 2006
October 2007   (final data collection date for primary outcome measure)
Prediction probability for prediction of anaesthetic endpoints [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: No ]
Prediction probability for prediction of anaesthetic endpoints
Complete list of historical versions of study NCT00455026 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Depth of Anaesthesia
Drug: remifentanil
target effect site concentration during induction
Other Name: No other names
  • Placebo Comparator: 1
    0 ng/ml target effect site concentration remifentanil
    Intervention: Drug: remifentanil
  • Active Comparator: 2
    2 ng/ml target concentration remifentanil
    Intervention: Drug: remifentanil
  • Active Comparator: 3
    4 ng/ml target effect site concentration remifentanil
    Intervention: Drug: remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00455026
2005.236
No
David Breeze, Cortical Dynamics
Melbourne Health
Biopharmica Limited
Principal Investigator: Kate Leslie, MD Melbourne Health
Melbourne Health
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP