Anesthesia, Surgery, Cardiac
Conditions
Brief summary
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.
Interventions
DEVICEAutomated postoperative sedation
DRUGpropofol
DRUGremifentanil
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* consent for participation * cardiac surgical procedure requiring postoperative sedation
Exclusion criteria
* pregnant women, * neurological or muscular disorder * high risk of revision surgery * patients having required a redo operation if the postoperative period of sedation was less than 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of sedation | 6 hours | Richmond Agitation-Sedation Scale measured until extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hemodynamics profile consecutive to a tracheal suctioning | 6 hours | — |
| 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 | 6 hours | Delay between the cessation of infusion of propofol and remifentanil and extubation. |
| 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 | — |
| Level of pain during sedation | 6 hours | Behavioral Pain Scale measured until extubation |
| 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 | 6 hours | Evolution of hemodynamic parameters (composite) |
| Level of consciousness after extubation | 6 hours | Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation |
| Pain after extubation | 6 hours | Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation |
| Awareness standardized questionnaire | 48 hours | — |
| Periods of electrical silence | 6 hours | Number and duration of electroencephalographic periods of silence |
Countries
France
Outcome results
None listed