Automated Postoperative Sedation After Cardiac Surgery (SEPOCA)

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

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

Study Overview

• Status: Terminated
• Conditions: Anesthesia; Sedation; Surgery, Cardiac
• Intervention / Treatment: Drug: Propofol; Drug: Remifentanil; Device: EasyTiva (algorithm is the property of Medsteer SAS)

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated postoperative sedation; Automated administration of Propofol and Remifentanil.	Drug: Propofol; The dosage is modified automatically by the device or according to the new medical prescription.; Drug: Remifentanil; The dosage is modified automatically by the device or according to the new medical prescription.; Device: EasyTiva (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.
Active Comparator: Manual postoperative sedation; Manual administration of Propofol and Remifentanil.	Drug: Propofol; The dosage is modified automatically by the device or according to the new medical prescription.; Drug: Remifentanil; The dosage is modified automatically by the device or according to the new medical prescription.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré
• Investigators: Study Chair: Thierry Chazot, MD, Hôpital Foch

Publications and helpful links

General Publications

• Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
• Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: 2017/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No