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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
  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 1

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

Resource links provided by NLM:

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
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            
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            
Sponsors and Collaborators
Melbourne Health
Biopharmica Limited
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health
  More Information

No publications provided

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

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 21, 2013