An interventional study of Device-guided sedation and standard sedation practice in Cardiac Surgical Procedures (Postoperative Population), Critical Illness and Postoperative Complications (Cardiopulmonary), sponsored by Medical University of Graz. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Supportive care
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 144 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
Compared within Postoperative Complications, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous BIS monitoring is visible to the care team. Sedation is titrated using BIS values plus routine clinical assessment, with instruction to avoid sustained BIS \< 50.
Other: Device-guided sedation
Sedation is managed per standard clinical practice using validated clinical scales (e.g., RASS). BIS monitoring is performed but hidden from caregivers (not used for clinical decisions).
Other: standard sedation practice
in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
sedation 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)
Time frame: immediately after discontinuation of propofol
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation in hours
Time frame: immediately after extubation
Duration of continuous sedation
Duration of continuous sedation in hours
Time frame: immediately after extubation
Incidence of pulmonary infections
pneumonie, tracheobronchial infections
Time frame: at ICU discharge
Proportion of time spent in deep sedation
Proportion of time during sedation with BIS values \<50
Time frame: immediately after discontinuation of Propofol
BIS values over time
Bispectral Index (BIS) is a monitoring system providing values from 0 to 100, reflecting brain activity with 100 being fully awake an 0 indicating no brain activity (isoelectric EEG). A range of 40-60 typicallysignifies adequate general anesthesia during surgery.
Time frame: immediately after discontinuation of Propofol
Length of ICU stay
Length of ICU stay in days
Time frame: at ICU discharge
Total hospital length of stay
Total hospital length of stay in days
Time frame: at hospital discharge
In-hospital mortality
Time frame: at ICU discharge
Incidence of ICU delirium
Incidence of ICU delirium (assessed using CAM-ICU or ICDSC)
Time frame: immediately after extubation
Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation
Time frame: immediately after discontinuation of Propofol
No study locations are listed for this record.
Plan to share: Yes — Types of data: De-identified individual participant data (IPD) underlying the primary and secondary outcomes (e.g., demographics, baseline characteristics, BIS values, sedation dosing, ventilation duration, ICU/hospital length of stay, delirium measures, adverse events). Supporting documents: Study protocol, statistical analysis plan (SAP), data dictionary/metadata, and analytic code.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: starting 12 months after publication of the primary results and for a period of 5 years thereafter
Access criteria: Available to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the Principal investigator. Approved requestors must: Sign a data use agreement (DUA) prohibiting re-identification and onward sharing. Obtain local IRB/ethics approval (or exemption) for the proposed analysis. Use data solely for the approved purpose and comply with GDPR and applicable data protection laws. Mode of access: Controlled access via the University Hospital Graz secure institutional repository. Instructions for requesting access will be provided via the study contact email: [selina.sartori@medunigraz.at]
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 8 months is below that.
Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.