Automated Postoperative Sedation After Cardiac Surgery

Anesthesia Clinical Trial

— SEPOCA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03517735
• Other study ID #: 2017/03
• Status: Terminated
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: October 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 30, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Sedation
• Surgery, Cardiac

Intervention

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.

Drug:
• Propofol
The dosage is modified automatically by the device or according to the new medical prescription.
• Remifentanil
The dosage is modified automatically by the device or according to the new medical prescription.

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

References & Publications (2)

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. 20 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate sedation	Percentage of time with BIS between 55 and 75 (BIS(55-75))	6 hours
Secondary	Period of too deep sedation	Percentage of time with BIS values less than 55	6 hours
Secondary	Period of too light sedation	Percentage of time with BIS values greater than 75	6 hours
Secondary	Incidence of Burst Suppression (bsr) during sedation	Presence of Burst Suppression defined by a rate > 10% for at least one minute	6 hours
Secondary	Level of sedation	Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm)	6 hours
Secondary	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
Secondary	Medical interventions	Number and causes of transient or permanent interruptions in automated administration	6 hours
Secondary	Hemodynamic status during the sedation period	Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm)	6 hours
Secondary	Sedation time	Duration of sedation	6 hours
Secondary	Delay before awakening	Delay between the cessation of infusion of propofol and remifentanil and extubation.	6 hours
Secondary	Dose of hypnotic drug	Total amount of propofol during sedation period	6 hours
Secondary	Dose of analgesic drug	Total amount of remifentanil during sedation period	6 hours
Secondary	Level of consciousness after extubation	Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm)	9 hours
Secondary	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
Secondary	Awareness during the sedation period	Awareness standardized questionnaire	48 hours