Automated Postoperative Sedation After Cardiac Surgery

Study Overview
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Brief Summary
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This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.

Detailed Description
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Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation. Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor. Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity. This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.

Official Title
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Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation

Conditions
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Anesthesia, Sedation, Surgery, Cardiac

Intervention / Treatment
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* Device: EasyTiva (algorithm is the property of Medsteer SAS)
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac surgical procedure requiring postoperative sedation Low operative risk : EuroSCORE 2 ≤ 5% Consent for participation Affiliation to the social security system Exclusion Criteria: Pregnant or breastfeeding women Neurological or muscular disorder Pacemaker Hypersensitivity to propofol or remifentanil Communication difficulties or neuropsychiatric disorder

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated postoperative sedation<br>Automated administration of Propofol and Remifentanil. | Device: EasyTiva (algorithm is the property of Medsteer SAS)<br>* Propofol and Remifentanil are administered 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 55 and 75.<br>Drug: Propofol<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>Drug: Remifentanil<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>|
| Active Comparator: Manual postoperative sedation<br>Manual administration of Propofol and Remifentanil. | Drug: Propofol<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>Drug: Remifentanil<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate sedation | Percentage of time with BIS between 55 and 75 (BIS(55-75)) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of too deep sedation | Percentage of time with BIS values less than 55 | 6 hours | 
| Period of too light sedation | Percentage of time with BIS values greater than 75 | 6 hours | 
| Incidence of Burst Suppression (bsr) during sedation | Presence of Burst Suppression defined by a rate > 10% for at least one minute | 6 hours | 
| Level of sedation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 6 hours | 
| Level of pain during sedation | Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed : Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing) Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted) Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation) | 6 hours | 
| Medical interventions | Number and causes of transient or permanent interruptions in automated administration | 6 hours | 
| Hemodynamic status during the sedation period | Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm) | 6 hours | 
| Sedation time | Duration of sedation | 6 hours | 
| Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation. | 6 hours | 
| Dose of hypnotic drug | Total amount of propofol during sedation period | 6 hours | 
| Dose of analgesic drug | Total amount of remifentanil during sedation period | 6 hours | 
| Level of consciousness after extubation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 9 hours | 
| Level of pain after extubation | Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed : Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing) Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted) Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation) | 9 hours | 
| Awareness during the sedation period | Awareness standardized questionnaire | 48 hours |