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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
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 (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

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 [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
0 ng/ml target effect site concentration remifentanil
 Drug: remifentanil
target effect site concentration during induction
Other Name: No other names
Active Comparator: 2
2 ng/ml target concentration remifentanil
 Drug: remifentanil
target effect site concentration during induction
Other Name: No other names
Active Comparator: 3
4 ng/ml target effect site concentration remifentanil
 Drug: remifentanil
target effect site concentration during induction
Other Name: No other names

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

Locations
Australia, Victoria
Swinburne University
Hawthorn, Victoria, Australia, 3123
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Biopharmica Limited
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health
  More Information

No publications provided

Responsible Party: David Breeze, Cortical Dynamics
ClinicalTrials.gov Identifier: NCT00455026     History of Changes
Other Study ID Numbers: 2005.236
Study First Received: April 1, 2007
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on June 18, 2013