Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

Completed

• Conditions: Cardiac Surgery
• Interventions: Device: Test of pharmacologic anesthesia robot (labVIEW® software)

• Registration Number: NCT02145585
• Lead Sponsor: University Hospital, Bordeaux

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic pharmacological system	Test of pharmacologic anesthesia robot (labVIEW® software)	Robotic pharmacological system/Automated anesthesia delivery system

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

CHU de Bordeaux - Hôpital Haut Lévêque; 🇫🇷 Pessac, France