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Clinical Trials/NCT02145585
NCT02145585
Completed
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country20 target enrollmentMarch 2014
ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
University Hospital, Bordeaux
Enrollment
20
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Time Frame: 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).

Study Sites (1)

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