Cardiac Surgery Clinical Trial
Official title:
Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study
Closed loop systems for anaesthesia have been shown to be more efficient than manual
administration and than Target Control Infusion systems (TCI). So far, there is only one
single-center study demonstrating that a system using simultaneously three closed loops for
each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe
and is more efficient than manual administration of anaesthetic drugs. Although the results
of this study are very encouraging, they are limited by its sample of patients recruited for
non-cardiac surgery only.
The hypothesis of the present trial is that cardiac anesthesia using a completely automated
anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia
and muscle relaxation) is feasible, safe and reliable.
Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on
patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.
Hypnosis is monitored during the surgery according to the brain activity values provided by
an objective monitoring parameter, called Bispectral Index (BIS).
A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be
determined clinically by recording the % of sedation time during which the actual BIS is
within 10% of the target BIS (excellent control), within 11 -20% (good control), between
21-30% (fair control) and beyond 30% of target (inadequate control).
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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