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.
Age ≥ 18 years
Undergoing cardiac surgery with subsequent admission to the intensive care unit (e.g., valve surgery, coronary artery bypass grafting, aortic surgery)
Planned or expected duration of invasive mechanical ventilation > 6 hours postoperatively
Requirement for continuous sedation during ICU stay
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.
Parallel
Device-guided sedation
Other interventionin addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
standard sedation practice
Other interventionsedation due to standard clinical practice, using sedation scores such as RASS-Score
time-averaged Propofol dose during continuous ICU sedation
mean Propofol infusion rate in mg/kg/h averaged over the continuous sedation period until discontinuation of Propofol (or switch to other sedative, return to OR or death)
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation in hours
Duration of continuous sedation
Duration of continuous sedation in hours
Incidence of pulmonary infections
pneumonie, tracheobronchial infections
Proportion of time spent in deep sedation
Proportion of time during sedation with BIS values \<50
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