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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00949-38 | Other Identifier | ANSM |
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Intermediate analysis
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This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated postoperative sedation | Experimental | Postoperative sedation is provided 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 40 and 60. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated postoperative sedation | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of sedation | Richmond Agitation-Sedation Scale measured until extubation | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain during sedation | Behavioral Pain Scale measured until extubation | 6 hours |
| Changes in hemodynamics profile consecutive to a tracheal suctioning | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Ambroise Paré | Neuilly-sur-Seine | Hauts-de-Seine | 92200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23223772 | Background | 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. |
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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 |
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| remifentanil | Drug |
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| Changes in Bispectral Index consecutive to a tracheal suctioning | 6 hours |
| Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning | 6 hours |
| Changes in Behavioral Pain Scale consecutive to a tracheal suctioning | 6 hours |
| Changes in concentration of propofol consecutive to a tracheal suctioning | 6 hours |
| Changes in concentration of remifentanil consecutive to a tracheal suctioning | 6 hours |
| Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation. | 6 hours |
| Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil | 6 hours |
| Calculation of indices of performance of the closed-loop system | 6 hours |
| Periods of electrical silence | Number and duration of electroencephalographic periods of silence | 6 hours |
| Total amounts of propofol observed during sedation period | 6 hours |
| Total amounts of remifentanil observed during sedation period | 6 hours |
| Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values | 6 hours |
| Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values. | 6 hours |
| Hemodynamic status during the sedation period | Evolution of hemodynamic parameters (composite) | 6 hours |
| Hemodynamic status during the sedation period | Number of medical interventions | 6 hours |
| Level of consciousness after extubation | Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation | 6 hours |
| Pain after extubation | Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation | 6 hours |
| Awareness standardized questionnaire | 48 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |