Postoperative Sedation After Cardiac Surgery (SEDCAR)

Hopital Foch

Status: Terminated

Conditions: Surgery, Cardiac; Anesthesia

Treatments: Drug: remifentanil; Device: Automated postoperative sedation; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02488486

2014/24

2014-A00949-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Automated postoperative sedation

Experimental group

Description:

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.

Treatment:

Drug: remifentanil

Device: Automated postoperative sedation

Drug: propofol