Study Results
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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TERMINATED
NA
7 participants
INTERVENTIONAL
2018-12-17
2019-03-30
Brief Summary
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Detailed Description
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Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.
Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.
This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
EasyTiva (algorithm is the property of Medsteer SAS)
Propofol and Remifentanil are administered automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 55 and 75.
Propofol
The dosage is modified automatically by the device or according to the new medical prescription.
Remifentanil
The dosage is modified automatically by the device or according to the new medical prescription.
Manual postoperative sedation
Manual administration of Propofol and Remifentanil.
Propofol
The dosage is modified automatically by the device or according to the new medical prescription.
Remifentanil
The dosage is modified automatically by the device or according to the new medical prescription.
Interventions
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EasyTiva (algorithm is the property of Medsteer SAS)
Propofol and Remifentanil are administered automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 55 and 75.
Propofol
The dosage is modified automatically by the device or according to the new medical prescription.
Remifentanil
The dosage is modified automatically by the device or according to the new medical prescription.
Eligibility Criteria
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Inclusion Criteria
* Low operative risk : EuroSCORE 2 ≤ 5%
* Consent for participation
* Affiliation to the social security system
Exclusion Criteria
* Neurological or muscular disorder
* Pacemaker
* Hypersensitivity to propofol or remifentanil
* Communication difficulties or neuropsychiatric disorder
18 Years
80 Years
ALL
No
Sponsors
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CMC Ambroise Paré
OTHER
Responsible Party
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Principal Investigators
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Thierry Chazot, MD
Role: STUDY_CHAIR
Hôpital FOCH
Locations
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CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France
Countries
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References
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Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.
Other Identifiers
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2017/03
Identifier Type: -
Identifier Source: org_study_id