Automated Postoperative Sedation After Cardiac Surgery

CMC Ambroise Paré7 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia Sedation Surgery, Cardiac

Interventions

EasyTiva (algorithm is the property of Medsteer SAS)DEVICE

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.

PropofolDRUG

The dosage is modified automatically by the device or according to the new medical prescription.

RemifentanilDRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, France

Outcomes

Primary Outcomes

Adequate sedation

Percentage of time with BIS between 55 and 75 (BIS(55-75))

Time frame: 6 hours

Secondary Outcomes

Period of too deep sedation

Percentage of time with BIS values less than 55

Time frame: 6 hours

Period of too light sedation

Percentage of time with BIS values greater than 75

Time frame: 6 hours

Incidence of Burst Suppression (bsr) during sedation

Presence of Burst Suppression defined by a rate \> 10% for at least one minute

Time frame: 6 hours

Level of sedation

Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \& calm)

Time frame: 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)

Time frame: 6 hours

Medical interventions

Number and causes of transient or permanent interruptions in automated administration

Time frame: 6 hours

Hemodynamic status during the sedation period

Data from ClinicalTrials.gov

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