Anesthesia, Sedation, Surgery, Cardiac
Conditions
Brief summary
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
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.
Interventions
DEVICEEasyTiva (algorithm is the property of Medsteer SAS)
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.
DRUGPropofol
The dosage is modified automatically by the device or according to the new medical prescription.
DRUGRemifentanil
The dosage is modified automatically by the device or according to the new medical prescription.
Sponsors
CMC Ambroise Paré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate sedation | 6 hours | Percentage of time with BIS between 55 and 75 (BIS(55-75)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period of too light sedation | 6 hours | Percentage of time with BIS values greater than 75 |
| Incidence of Burst Suppression (bsr) during sedation | 6 hours | Presence of Burst Suppression defined by a rate \> 10% for at least one minute |
| Level of sedation | 6 hours | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) |
| Level of pain during sedation | 6 hours | 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) |
| Medical interventions | 6 hours | Number and causes of transient or permanent interruptions in automated administration |
| Hemodynamic status during the sedation period | 6 hours | Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm) |
| Period of too deep sedation | 6 hours | Percentage of time with BIS values less than 55 |
| Delay before awakening | 6 hours | Delay between the cessation of infusion of propofol and remifentanil and extubation. |
| Dose of hypnotic drug | 6 hours | Total amount of propofol during sedation period |
| Dose of analgesic drug | 6 hours | Total amount of remifentanil during sedation period |
| Level of consciousness after extubation | 9 hours | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) |
| Level of pain after extubation | 9 hours | 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) |
| Awareness during the sedation period | 48 hours | Awareness standardized questionnaire |
| Sedation time | 6 hours | Duration of sedation |
Countries
France
Outcome results
None listed