Cardiac Surgical Procedures (Postoperative Population)NCT07350122
BIS in ICU Interventional Study
A study testing Device-guided sedation and standard sedation practice in people with Cardiac Surgical Procedures (Postoperative Population) and Critical Illness, run by Medical University of Graz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures (Postoperative Population), Critical Illness, Postoperative Complications (Cardiopulmonary)
- What is being tested?
- Device-guided sedation and standard sedation practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Do-not-intubate (DNI)/Do-not-resuscitate (DNR) orders or documented limitation of therapy.
- Patients in whom short-term survival is deemed unlikely due to the clinical course.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial
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.
Read more
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
- Being tested
- Device-guided sedation, standard sedation practice
- Medical subject headings
- Critical Illness, Postoperative Complications, Emergence Delirium, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-guided sedationOther
in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
standard sedation practiceOther
sedation due to standard clinical practice, using sedation scores such as RASS-Score
| Study group | Role | What they receive |
|---|---|---|
| BIS-Guided Sedation | Experimental | 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. Receives: Other: Device-guided sedation |
| Standard Sedation with Blinded BIS | Active comparator | 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). Receives: Other: standard sedation practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately after discontinuation of propofol
Secondary outcomes (10)
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation in hours
Measured: immediately after extubation
Duration of continuous sedation
Duration of continuous sedation in hours
Measured: immediately after extubation
Incidence of pulmonary infections
pneumonie, tracheobronchial infections
Measured: at ICU discharge
Proportion of time spent in deep sedation
Proportion of time during sedation with BIS values <50
Measured: 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.
Measured: immediately after discontinuation of Propofol
Length of ICU stay
Length of ICU stay in days
Measured: at ICU discharge
Total hospital length of stay
Total hospital length of stay in days
Measured: at hospital discharge
In-hospital mortality
Measured: at ICU discharge
Incidence of ICU delirium
Incidence of ICU delirium (assessed using CAM-ICU or ICDSC)
Measured: immediately after extubation
Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation
Measured: immediately after discontinuation of Propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical Procedures (Postoperative Population)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350122
- Sponsor's protocol ID
- 1579
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07350122
- Acronym / sponsor ID
- 1579
- Conditions
- Cardiac Surgical Procedures (Postoperative Population), Critical Illness, Postoperative Complications (Cardiopulmonary), Delirium - Postoperative, Pneumonia, Ventilator-Associated
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS-Guided Sedation | Experimental | Other: Device-guided sedationContinuous 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. |
| Standard Sedation with Blinded BIS | Active comparator | Other: standard sedation practiceSedation 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device-guided sedationin addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation | Other | BIS-Guided Sedation |
| standard sedation practicesedation due to standard clinical practice, using sedation scores such as RASS-Score | Other | Standard Sedation with Blinded BIS |
Primary outcome
time-averaged Propofol dose during continuous ICU sedation
Time frame: immediately after discontinuation of propofol
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)
10 secondary outcomes
Duration of invasive mechanical ventilation
Time frame: immediately after extubation
Duration of continuous sedation
Time frame: immediately after extubation
Incidence of pulmonary infections
Time frame: at ICU discharge
Proportion of time spent in deep sedation
Time frame: immediately after discontinuation of Propofol
BIS values over time
Time frame: immediately after discontinuation of Propofol
Length of ICU stay
Time frame: at ICU discharge
Total hospital length of stay
Time frame: at hospital discharge
In-hospital mortality
Time frame: at ICU discharge
Incidence of ICU delirium
Time frame: immediately after extubation
Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation
Time frame: immediately after discontinuation of Propofol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Device-guided sedation and standard sedation practice in people with Cardiac Surgical Procedures (Postoperative Population) and Critical Illness, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selina Sartori, MD (+43 664 1652783, selina.sartori@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-averaged Propofol dose during continuous ICU sedation (time frame: immediately after discontinuation of propofol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.