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Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery

NCT ID: NCT02145585

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Cardiac Surgery

Keywords

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Cardiac surgery Robotic pharmacological anesthesia Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic pharmacological system

Robotic pharmacological system/Automated anesthesia delivery system

Test of pharmacologic anesthesia robot (labVIEW® software)

Intervention Type DEVICE

Interventions

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Test of pharmacologic anesthesia robot (labVIEW® software)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cédrick ZAOUTER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX RNI 01/2014

Identifier Type: -

Identifier Source: org_study_id