Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

This study is currently recruiting participants.

Verified by Melbourne Health, March 2007

First Received: April 1, 2007 Last Updated: April 2, 2007 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Remifentanil hydrochloride Remifentanil

U.S. FDA Resources

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

No publications provided

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

Study placed in the following topic categories:

Anesthetics, Intravenous
Remifentanil
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Analgesics
Propofol
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
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 September 10, 2009