Automated Postoperative Sedation After Cardiac Surgery

Not Applicable

Terminated

• Conditions: Anesthesia; Sedation; Surgery, Cardiac
• Interventions: Device: EasyTiva (algorithm is the property of Medsteer SAS); Drug: Propofol; Drug: Remifentanil

• Registration Number: NCT03517735
• Lead Sponsor: CMC Ambroise Paré

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.

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-07
• Study Start: 2018-12-17
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated postoperative sedation	EasyTiva (algorithm is the property of Medsteer SAS)	Automated administration of Propofol and Remifentanil.
Automated postoperative sedation	Propofol	Automated administration of Propofol and Remifentanil.
Automated postoperative sedation	Remifentanil	Automated administration of Propofol and Remifentanil.
Manual postoperative sedation	Remifentanil	Manual administration of Propofol and Remifentanil.
Manual postoperative sedation	Propofol	Manual administration of Propofol and Remifentanil.

Primary Outcome Measures

Name	Time	Method
Adequate sedation	6 hours	Percentage of time with BIS between 55 and 75 (BIS(55-75))

Secondary Outcome Measures

Name	Time	Method
Level of sedation	6 hours	Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \& calm)
Dose of hypnotic drug	6 hours	Total amount of propofol during sedation period
Awareness during the sedation period	48 hours	Awareness standardized questionnaire
Period of too light sedation	6 hours	Percentage of time with BIS values greater than 75
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)
Period of too deep sedation	6 hours	Percentage of time with BIS values less than 55
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)
Incidence of Burst Suppression (bsr) during sedation	6 hours	Presence of Burst Suppression defined by a rate \> 10% for at least one minute
Medical interventions	6 hours	Number and causes of transient or permanent interruptions in automated administration
Sedation time	6 hours	Duration of sedation
Delay before awakening	6 hours	Delay between the cessation of infusion of propofol and remifentanil and extubation.
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)
Hemodynamic status during the sedation period	6 hours	Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm)

Trial Locations

Locations (1)

CMC Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, Ile-de-France, France