Automated Postoperative Sedation After Cardiac Surgery (SEPOCA)

CMC Ambroise Paré

Status: Terminated

Conditions: Surgery, Cardiac; Sedation; Anesthesia

Treatments: Drug: Remifentanil; Drug: Propofol; Device: EasyTiva (algorithm is the property of Medsteer SAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03517735

2017/03

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

Automated postoperative sedation

Experimental group

Description:

Automated administration of Propofol and Remifentanil.

Treatment:

Drug: Propofol

Drug: Remifentanil

Device: EasyTiva (algorithm is the property of Medsteer SAS)

Manual postoperative sedation

Active Comparator group

Description:

Manual administration of Propofol and Remifentanil.

Treatment:

Drug: Propofol

Drug: Remifentanil