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Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

NCT02145585 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2014-12-18

No results posted yet for this study

Summary

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).

Conditions

  • Cardiac Surgery

Interventions

DEVICE

Test of pharmacologic anesthesia robot (labVIEW® software)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Cédrick ZAOUTER, MD · University Hospital, Bordeaux

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145585 on ClinicalTrials.gov