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Completed

NCT Number: NCT00455026

Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

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.

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Key information

Conditions

Depth of Anaesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Swinburne University, Hawthorn, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

target effect site concentration during induction

Other names: No other names

Primary outcomes

  1. Prediction probability for prediction of anaesthetic endpoints

    Time frame: During induction of anaesthesia

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Collaborators

  • Biopharmica Limited

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 3, 2007
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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