Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Melbourne Health.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Biopharmica Limited

Information provided by:

Melbourne Health

ClinicalTrials.gov Identifier:

NCT00455026

First received: April 1, 2007

Last updated: April 2, 2007

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2007

Last Updated Date

April 2, 2007

Start Date ^ICMJE

March 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Prediction probability for prediction of anaesthetic endpoints

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00455026 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Official Title ^ICMJE

Not Provided

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic

Condition ^ICMJE

Depth of Anaesthesia

Intervention ^ICMJE

Drug: remifentanil

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kate Leslie, MD

61-3-93427000 ext 27540

kate.leslie@mh.org.au

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00455026

Other Study ID Numbers ^ICMJE

2005.236

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Melbourne Health

Collaborators ^ICMJE

Biopharmica Limited

Investigators ^ICMJE

Principal Investigator:

Kate Leslie, MD

Melbourne Health

Information Provided By

Melbourne Health

Verification Date

March 2007

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

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