NCT07350122

BIS in ICU Interventional Study

Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS). About 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded. Participants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg/kg/h) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality. Risks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.

Conditions

• Cardiac Surgical Procedures (Postoperative Population)
• Critical Illness
• Postoperative Complications (Cardiopulmonary)
• Delirium - Postoperative
• Pneumonia, Ventilator-Associated

Interventions

Type	Name	Description
OTHER	Device-guided sedation	in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
OTHER	standard sedation practice	sedation due to standard clinical practice, using sedation scores such as RASS-Score

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-05-01
• Completion: 2027-06-01
• First posted: 2026-01-20
• Last updated: 2026-01-20