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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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