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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Clinique Ambroise Paré
Neuilly-sur-Seine, Hauts-de-Seine, France
Level of sedation
Richmond Agitation-Sedation Scale measured until extubation
Time frame: 6 hours
Level of pain during sedation
Behavioral Pain Scale measured until extubation
Time frame: 6 hours
Changes in hemodynamics profile consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Bispectral Index consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Behavioral Pain Scale consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in concentration of propofol consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in concentration of remifentanil consecutive to a tracheal suctioning
Time frame: 6 hours
Delay before awakening
Delay between the cessation of infusion of propofol and remifentanil and extubation.
Time frame: 6 hours
Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil
Time frame: 6 hours
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Calculation of indices of performance of the closed-loop system
Time frame: 6 hours
Periods of electrical silence
Number and duration of electroencephalographic periods of silence
Time frame: 6 hours
Total amounts of propofol observed during sedation period
Time frame: 6 hours
Total amounts of remifentanil observed during sedation period
Time frame: 6 hours
Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values
Time frame: 6 hours
Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.
Time frame: 6 hours
Hemodynamic status during the sedation period
Evolution of hemodynamic parameters (composite)
Time frame: 6 hours
Hemodynamic status during the sedation period
Number of medical interventions
Time frame: 6 hours
Level of consciousness after extubation
Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation
Time frame: 6 hours
Pain after extubation
Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation
Time frame: 6 hours
Awareness standardized questionnaire
Time frame: 48 hours