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Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

NCT02145585 · University Hospital, Bordeaux · Updated 18 Dec 2014

What is being tested
Test of pharmacologic anesthesia robot (labVIEW® software)
For
Cardiac Surgery
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 20 people. The full rules are on the registry page.
Where
France
When
Starts or started March 2014, ends May 2014. Registered 23 May 2014.
Results
None posted yet.

In the researchers' words

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%…
ClinicalTrials.gov, NCT02145585

Sites

  • CHU de Bordeaux - Hôpital Haut LévêquePessac, France