Postoperative Sedation After Cardiac Surgery (SEDCAR)

Postoperative Sedation After Cardiac Surgery: Pilot Study

This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.

Study Overview

• Status: Terminated
• Conditions: Anesthesia; Surgery, Cardiac
• Intervention / Treatment: Drug: propofol; Drug: remifentanil; Device: Automated postoperative sedation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
      • Clinique Ambroise Pare

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:

• consent for participation
• cardiac surgical procedure requiring postoperative sedation

Exclusion Criteria:

• pregnant women,
• neurological or muscular disorder
• high risk of revision surgery
• patients having required a redo operation if the postoperative period of sedation was less than 2 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated postoperative sedation; Postoperative sedation is provided 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 40 and 60.	Drug: propofol; Drug: remifentanil; Device: Automated postoperative sedation; Other Names: algorithm is the property of Medsteer SAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of sedation	Richmond Agitation-Sedation Scale measured until extubation	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay before awakening	Delay between the cessation of infusion of propofol and remifentanil and extubation.	6 hours
Level of pain during sedation	Behavioral Pain Scale measured until extubation	6 hours
Changes in hemodynamics profile consecutive to a tracheal suctioning		6 hours
Changes in Bispectral Index consecutive to a tracheal suctioning		6 hours
Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning		6 hours
Changes in Behavioral Pain Scale consecutive to a tracheal suctioning		6 hours
Changes in concentration of propofol consecutive to a tracheal suctioning		6 hours
Changes in concentration of remifentanil consecutive to a tracheal suctioning		6 hours
Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil		6 hours
Calculation of indices of performance of the closed-loop system		6 hours
Periods of electrical silence	Number and duration of electroencephalographic periods of silence	6 hours
Total amounts of propofol observed during sedation period		6 hours
Total amounts of remifentanil observed during sedation period		6 hours
Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values		6 hours
Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.		6 hours
Hemodynamic status during the sedation period	Evolution of hemodynamic parameters (composite)	6 hours
Hemodynamic status during the sedation period	Number of medical interventions	6 hours
Level of consciousness after extubation	Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation	6 hours
Pain after extubation	Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation	6 hours
Awareness standardized questionnaire		48 hours

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• 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: May 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

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: 2014/24; 2014-A00949-38 (Other Identifier: ANSM)