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Modification of the device
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This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.
Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated postoperative sedation | Experimental | Automated administration of Propofol and Remifentanil. |
|
| Manual postoperative sedation | Active Comparator | Manual administration of Propofol and Remifentanil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EasyTiva (algorithm is the property of Medsteer SAS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate sedation | Percentage of time with BIS between 55 and 75 (BIS(55-75)) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Period of too deep sedation | Percentage of time with BIS values less than 55 | 6 hours |
| Period of too light sedation | Percentage of time with BIS values greater than 75 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Chazot, MD | Hôpital FOCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21233500 | Result | 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. | |
| 23223772 |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Propofol | Drug | The dosage is modified automatically by the device or according to the new medical prescription. |
|
| Remifentanil | Drug | The dosage is modified automatically by the device or according to the new medical prescription. |
|
| 6 hours |
| Incidence of Burst Suppression (bsr) during sedation | Presence of Burst Suppression defined by a rate > 10% for at least one minute | 6 hours |
| Level of sedation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 6 hours |
| Level of pain during sedation | Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :
| 6 hours |
| Medical interventions | Number and causes of transient or permanent interruptions in automated administration | 6 hours |
| Hemodynamic status during the sedation period | Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm) | 6 hours |
| Sedation time | Duration of sedation | 6 hours |
| Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation. | 6 hours |
| Dose of hypnotic drug | Total amount of propofol during sedation period | 6 hours |
| Dose of analgesic drug | Total amount of remifentanil during sedation period | 6 hours |
| Level of consciousness after extubation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 9 hours |
| Level of pain after extubation | Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :
| 9 hours |
| Awareness during the sedation period | Awareness standardized questionnaire | 48 hours |
| 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |