Skip to content

Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02145585
Enrollment
20
Registered
2014-05-23
Start date
2014-03-31
Completion date
2014-05-31
Last updated
2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac surgery, Robotic pharmacological anesthesia, Anesthesia

Brief 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).

Interventions

DEVICETest of pharmacologic anesthesia robot (labVIEW® software)

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective patients * Patients scheduled to receive an extracorporeal circulation * Patients aged 18 and older

Exclusion criteria

* Minor * Unable to provide informed consent * Comatose patients * Patients with dementia * Patient who underwent neurosurgery * Pregnant women * Patient with muscle disease * Allergy to Propofol and/or remifentanil

Design outcomes

Primary

MeasureTime frameDescription
Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.at inclusion (day 0)Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026