Postoperative Sedation After Cardiac Surgery
Not Applicable
Terminated
- Conditions
- Surgery, CardiacAnesthesia
- Interventions
- Registration Number
- NCT02488486
- Lead Sponsor
- Hopital Foch
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Automated postoperative sedation Automated postoperative sedation 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. Automated postoperative sedation remifentanil 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. Automated postoperative sedation propofol 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.
- Primary Outcome Measures
Name Time Method Level of sedation 6 hours Richmond Agitation-Sedation Scale measured until extubation
- Secondary Outcome Measures
Name Time Method Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning 6 hours Changes in concentration of propofol consecutive to a tracheal suctioning 6 hours Level of pain during sedation 6 hours Behavioral Pain Scale measured until extubation
Hemodynamic status during the sedation period 6 hours Number of medical interventions
Changes in hemodynamics profile consecutive to a tracheal suctioning 6 hours Changes in Bispectral Index consecutive to a tracheal suctioning 6 hours Changes in Behavioral Pain Scale consecutive to a tracheal suctioning 6 hours Level of consciousness after extubation 6 hours Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation
Changes in concentration of remifentanil consecutive to a tracheal suctioning 6 hours Calculation of indices of performance of the closed-loop system 6 hours Total amounts of propofol observed during sedation period 6 hours Pain after extubation 6 hours Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation
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 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 Periods of electrical silence 6 hours Number and duration of electroencephalographic periods of silence
Awareness standardized questionnaire 48 hours
Trial Locations
- Locations (1)
Clinique Ambroise Paré
đŸ‡«đŸ‡·Neuilly-sur-Seine, Hauts-de-Seine, France