Clinical trial NCT02488486: Postoperative Sedation After Cardiac Surgery
Official title: Postoperative Sedation After Cardiac Surgery: Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery, Cardiac
Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of sedation
timeFrame: 6 hours
Secondary outcomes:
measure: Level of pain during sedation
timeFrame: 6 hours
measure: Changes in hemodynamics profile consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Changes in Bispectral Index consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Changes in Behavioral Pain Scale consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Changes in concentration of propofol consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Changes in concentration of remifentanil consecutive to a tracheal suctioning
timeFrame: 6 hours
measure: Delay before awakening
timeFrame: 6 hours
measure: Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil
timeFrame: 6 hours
measure: Calculation of indices of performance of the closed-loop system
timeFrame: 6 hours
measure: Periods of electrical silence
timeFrame: 6 hours
measure: Total amounts of propofol observed during sedation period
timeFrame: 6 hours
measure: Total amounts of remifentanil observed during sedation period
timeFrame: 6 hours
measure: Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values
timeFrame: 6 hours
measure: Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.
timeFrame: 6 hours
measure: Hemodynamic status during the sedation period
timeFrame: 6 hours
measure: Hemodynamic status during the sedation period
timeFrame: 6 hours
measure: Level of consciousness after extubation
timeFrame: 6 hours
measure: Pain after extubation
timeFrame: 6 hours
measure: Awareness standardized questionnaire
timeFrame: 48 hours
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
state: Hauts-de-Seine
Study officials:
References:
citation: 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.