Postoperative Sedation After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Sedation After Cardiac Surgery: Pilot Study

Conditions
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Surgery, Cardiac, Anesthesia

Intervention / Treatment
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* Device: Automated postoperative sedation
* Drug: propofol
* Drug: remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated postoperative sedation<br>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. | Device: Automated postoperative sedation<br> <br> * Other names: algorithm is the property of Medsteer SAS;Drug: propofol<br> <br> Drug: remifentanil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of sedation | Richmond Agitation-Sedation Scale measured until extubation | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |