NCT03517735

Automated Postoperative Sedation After Cardiac Surgery

Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.

Detailed description

Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation. Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor. Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity. This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.

Conditions

• Anesthesia
• Sedation
• Surgery, Cardiac

Interventions

Type	Name	Description
DEVICE	EasyTiva (algorithm is the property of Medsteer SAS)	Propofol and Remifentanil are administered 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 55 and 75.
DRUG	Propofol	The dosage is modified automatically by the device or according to the new medical prescription.
DRUG	Remifentanil	The dosage is modified automatically by the device or according to the new medical prescription.

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-03-28
• Completion: 2019-03-30
• First posted: 2018-05-07
• Last updated: 2021-11-05

Locations

1 site across 1 country: France