Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia - Full Text View

Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

This study is currently recruiting participants.
Verified by Melbourne Health, March 2007

Sponsors and Collaborators:	Melbourne Health Biopharmica Limited
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00455026

Purpose

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.

Condition	Intervention	Phase
Depth of Anaesthesia	Drug: remifentanil	Phase I

MedlinePlus related topics:

Anesthesia

Drug Information available for:

Propofol Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

Prediction probability for prediction of anaesthetic endpoints

Estimated Enrollment:	45
Study Start Date:	March 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455026

Contacts


Contact: Kate Leslie, MD	61-3-93427000 ext 27540	kate.leslie@mh.org.au

Locations


Australia, Victoria
	Royal Melbourne Hospital	Recruiting
	Parkville, Victoria, Australia, 3050
	Contact: Kate Leslie, MD 61-3-93427000 ext 27540 kate.leslie@mh.org.au
	Principal Investigator: Kate Leslie, MD
	Swinburne University	Not yet recruiting
	Hawthorn, Victoria, Australia, 3123
	Contact: David Liley, PhD 61-3-92148812 dliley@swin.edu.au
	Principal Investigator: David Lilley, PhD

Sponsors and Collaborators

Melbourne Health

Biopharmica Limited

Investigators


Principal Investigator:	Kate Leslie, MD	Melbourne Health

More Information

Study ID Numbers:	2005.236
First Received:	April 1, 2007
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00455026
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Remifentanil

Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Pharmacologic Actions

Sensory System Agents

Anesthetics, General

Therapeutic Uses

Hypnotics and Sedatives

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 21, 2008