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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00455026
Study type Interventional
Source Melbourne Health
Contact
Status Completed
Phase Phase 1
Start date March 2006
Completion date October 2007

See also
  Status Clinical Trial Phase
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Completed NCT00793663 - Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia Phase 4
Completed NCT03209323 - Epileptiform EEG Patterns During Induction of General Anaesthesia With Sevoflurane Compared to Those With Propofol N/A
Completed NCT00226837 - Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling Phase 4