RecruitingNCT07350109

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

An Explorative Prospective Non-interventional Study on Sedation Depth in Postoperative Cardiac Surgery Patients Using Blinded BIS Monitoring


Sponsor

Medical University of Graz

Enrollment

50 participants

Start Date

Nov 22, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥ 18 years.
  • Undergoing cardiac surgery with subsequent admission to the ICU
  • expected duration of invasive mechanical ventilation \> 6 hours postop.
  • Written informed consent obtained from the patient or legal representative (if the patient is not capable of consent).

Exclusion Criteria6

  • Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy).
  • Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage).
  • Severe hepatic dysfunction (Child-Pugh Class C).
  • Participation in another interventional study potentially affecting sedation or cognitive outcomes.
  • Pregnancy or lactation.
  • Patients in whom short-term survival is deemed unlikely due to clinical course

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(2)

Medical University Graz

Graz, Styria, Austria

Klinikum Wels

Wels, Upper Austria, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07350109