None listed
Conditions
Brief 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.
Interventions
Fentanyl moderate dose 24mcg/kg IV on induction
Sponsors
Cortical Dynamics
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed