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Automated Postoperative Sedation After Cardiac Surgery

NCT03517735 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-11-05

No results posted yet for this study

Summary

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

Conditions

  • Anesthesia
  • Sedation
  • Surgery, Cardiac

Interventions

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.

Sponsors & Collaborators

  • CMC Ambroise Paré

    lead OTHER

Principal Investigators

  • Thierry Chazot, MD · Hôpital FOCH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2019-03-28
Completion
2019-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517735 on ClinicalTrials.gov