Clinical Trial

Investigation of Sedation Depth Via BIS Monitoring in ICU After Cardiac Surgery

Study acronym: BISICU
Completed
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Summary
This study is a non-interventional, observational research project focused on monitoring sedation levels in patients who have undergone cardiac surgery. It uses a tool called Bispectral Index (BIS), which measures brain activity to assess sedation depth. The goal is to understand how often patients experience deep sedation (BIS \<50) during the first 48 hours in the ICU and to explore its impact on clinical outcomes like ventilation duration, ICU stay length, and complications such as infections or delirium. The study is conducted at two hospitals in Austria and involves patients who require mechanical ventilation and continuous sedation for more than six hours after surgery. BIS data will be collected continuously, but the readings will be blinded to the clinical team, meaning they will not influence patient care. Sedation will be managed using standard clinical practices. The findings aim to improve sedation management in ICUs.
Protocol Amendment History 1 change
critical Trial completed 2026-05-30
Trial Details
NCT Number NCT07350109
Lead Sponsor Medical University of Graz
Conditions Sedation After Cardiac Surgery
Enrollment 50 participants
Start Date 2025-11-22
Primary Completion 2026-03-25 (estimated)
Study Completion 2026-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-05-29