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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02488486
Date of registration:	26/06/2015
Prospective Registration:	No
Primary sponsor:	Hopital Foch
Public title:	Postoperative Sedation After Cardiac Surgery SEDCAR
Scientific title:	Postoperative Sedation After Cardiac Surgery: Pilot Study
Date of first enrolment:	May 2015
Target sample size:	19
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02488486
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Surgery, Cardiac

Anesthesia

Intervention(s)

Drug: propofol

Drug: remifentanil

Device: Automated postoperative sedation

Primary Outcome(s)

Level of sedation [Time Frame: 6 hours]

Secondary Outcome(s)

Level of pain during sedation [Time Frame: 6 hours]

Total amounts of propofol observed during sedation period [Time Frame: 6 hours]

Changes in concentration of remifentanil consecutive to a tracheal suctioning [Time Frame: 6 hours]

Delay before awakening [Time Frame: 6 hours]

Changes in Bispectral Index consecutive to a tracheal suctioning [Time Frame: 6 hours]

Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil [Time Frame: 6 hours]

Level of consciousness after extubation [Time Frame: 6 hours]

Total amounts of remifentanil observed during sedation period [Time Frame: 6 hours]

Hemodynamic status during the sedation period [Time Frame: 6 hours]

Awareness standardized questionnaire [Time Frame: 48 hours]

Calculation of indices of performance of the closed-loop system [Time Frame: 6 hours]

Changes in Behavioral Pain Scale consecutive to a tracheal suctioning [Time Frame: 6 hours]

Changes in concentration of propofol consecutive to a tracheal suctioning [Time Frame: 6 hours]

Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values. [Time Frame: 6 hours]

Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values [Time Frame: 6 hours]

Changes in hemodynamics profile consecutive to a tracheal suctioning [Time Frame: 6 hours]

Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning [Time Frame: 6 hours]

Periods of electrical silence [Time Frame: 6 hours]

Pain after extubation [Time Frame: 6 hours]

Secondary ID(s)

2014-A00949-38

2014/24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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