Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

NCT02145585 | Completed

• 1 other identifier: CHUBX RNI 01/2014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Surgery

Keywords

Cardiac surgery; Robotic pharmacological anesthesia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

  at inclusion (day 0)

Study Arms (1)

Robotic pharmacological system

Robotic pharmacological system/Automated anesthesia delivery system

Device: Test of pharmacologic anesthesia robot (labVIEW® software)

Interventions

Test of pharmacologic anesthesia robot (labVIEW® software) DEVICE

Robotic pharmacological system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective cardiac surgery with extracorporeal circulation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, 33604, France

Location

Study Officials

• Cédrick ZAOUTER, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 23, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

FR (1)