Postoperative Sedation After Cardiac Surgery

Anesthesia Clinical Trial

— SEDCAR  

Official title:

Postoperative Sedation After Cardiac Surgery: Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488486
• Other study ID #: 2014/24
• Secondary ID: 2014-A00949-38
• Status: Terminated
• Phase: N/A
• First received: June 26, 2015
• Last updated: May 16, 2017
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Surgery, Cardiac

Intervention

Device:
• Automated postoperative sedation

Drug:
• propofol

• remifentanil

Locations

Country	Name	City	State
France	Clinique Ambroise Paré	Neuilly-sur-Seine	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

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