drugset / Trial / NCT03517735

Automated Postoperative Sedation After Cardiac Surgery

NCT03517735 ↗

Terminated 7 enrolled CMC Ambroise Paré
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

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

Outcome

Met primary endpoint

Stopped: “Modification of the device”

paper Adequate sedation (BIS(40-60)) was significantly more frequent in the automated group 77 [59-82] % than in the manual group 36 [22-56] %, with p = 0.001. PMID 23223772 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule — Intravenous
Subject Remifentanil Small molecule — Intravenous

Indications

No indication recorded.