CompletedPhase 4ACTRN12611000978965

Validation of the Brain Anaesthesia Response (BAR) Monitoring System during Anaesthesia for Cardiac Surgery: a Double-Blinded, Randomised, Controlled Trial using Two Different Doses of Fentanyl.


Sponsor

Cortical Dynamics

Enrollment

24 participants

Start Date

Dec 12, 2011

Study Type

Interventional

Conditions

Summary

The Brain Anaesthesia Response (BAR) monitor system is designed to non-invasively monitor brain function in response to anaesthetic and sedative agents. Electroencephalography (EEG) signals are collected using the sensor which is applied to the patients’ forehead. The signals are processed to calculate two BAR indices, Cortical State (CS) and Cortical Input (CI). The displayed indices are designed to assist the anaesthetist to estimate the levels of consciousness and analgesia of a patient during general anaesthesia. The study is designed to investigate whether the BAR indices recorded in the operating room environment can distinguish between two groups of patients anaesthetised with either a low or a moderate dose of fentanyl and show clinically meaningful correlations with levels of hypnosis.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Males and females aged 18 to 80 years undergoing elective first-time coronary artery bypass graft surgery with American Society of Anaesthesiologist Classification III or IV

Exclusion Criteria1

  • Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability Epilepsy or other conditions which may affect the EEG History of prescription or illicit drug use known to affect the EEG Body Weight > 120 kg Allergy to trial medications Uncontrolled hyper- or hypotension, congestive cardiac failure or an ejection fraction of < 25% Permanent or temporary pacemaker in situ

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Interventions

Fentanyl moderate dose 24mcg/kg IV on induction

Fentanyl moderate dose 24mcg/kg IV on induction


Locations(1)

Australia

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ACTRN12611000978965