Sedation After Cardiac SurgeryBISICUNCT07350109
Investigation of Sedation Depth Via BIS Monitoring in ICU After Cardiac Surgery
An observational study of Sedation After Cardiac Surgery, run by Medical University of Graz at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation After Cardiac Surgery
- How many people
- 50 participants
- Where
- 2 sitesAustria
- Study dates
- 22 Nov 2025to 26 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patients admitted to the ICU following cardiac surgery. These patients are expected to require invasive mechanical ventilation and continuous sedation for more than 6 hours postoperatively.
Who may be able to join
- 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).
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.
- Patients in whom short-term survival is deemed unlikely due to clinical course
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Graz
Graz, Styria, 8010
Klinikum Wels
Wels, Upper Austria, 4600
About this study
Official title: An Explorative Prospective Non-interventional Study on Sedation Depth in Postoperative Cardiac Surgery Patients Using Blinded BIS Monitoring
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.
- Conditions
- Sedation After Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | adult patients who have undergone cardiac surgery expected to require invasive mechanical ventilation and continuous sedation for more than six hours postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time spent in deep sedation
BIS <50
Measured: immediately after extubation or up to 48 hours of ICU sedation - whichever comes first
Secondary outcomes (7)
Duration of mechanical ventilation
Measured: immediately after extubation
Incidence of pulmonary infection
any kind of pulmonary infection, including tracheobronchitis, pneumonia
Measured: immediately after ICU discharge
Incidence of ICU delirium
assessed using CAM-ICU or ICDSC
Measured: immediately after extubation
Time average of vasopressor dose
Time average of Noradrenaline dose
Measured: immediately after extubation or after 48 hours of invasive ventilation
ICU and hospital LOS
in days
Measured: immediately after hospital discharge
in hospital mortality
Measured: immediately after hospital discharge
Incidence of BIS suppression events
episodes where the suppression ratio exceeds 10%, indicating potential over-sedation or EEG suppression
Measured: immediately after extubation or after 48 hours of invasive ventilation
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 start22 Nov 2025
- Primary completion25 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation After Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
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
- NCT07350109
- Sponsor's protocol ID
- 1368
- Acronym
- BISICU
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Prospective Non-interventional Study on Sedation Depth in Postoperative Cardiac Surgery Patients Using Blinded BIS Monitoring
- ClinicalTrials.gov ID
- NCT07350109
- Acronym / sponsor ID
- BISICU / 1368
- Conditions
- Sedation After Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –adult patients who have undergone cardiac surgery expected to require invasive mechanical ventilation and continuous sedation for more than six hours postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the ICU following cardiac surgery. These patients are expected to require invasive mechanical ventilation and continuous sedation for more than 6 hours postoperatively.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 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.
Primary outcome
Proportion of time spent in deep sedation
Time frame: immediately after extubation or up to 48 hours of ICU sedation - whichever comes first
BIS <50
7 secondary outcomes
Duration of mechanical ventilation
Time frame: immediately after extubation
Incidence of pulmonary infection
Time frame: immediately after ICU discharge
Incidence of ICU delirium
Time frame: immediately after extubation
Time average of vasopressor dose
Time frame: immediately after extubation or after 48 hours of invasive ventilation
ICU and hospital LOS
Time frame: immediately after hospital discharge
in hospital mortality
Time frame: immediately after hospital discharge
Incidence of BIS suppression events
Time frame: immediately after extubation or after 48 hours of invasive ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Sedation After Cardiac Surgery
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Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study
Patient Scheduled for Surgery
Active, not recruitingObservational study
Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window
Pericardial Effusion, Inflammatory Response After Surgery
RecruitingPhase 4
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
Effect of Drug, Adverse Drug Event
RecruitingPhase 4
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
Delirium, Cognitive Dysfunction
RecruitingPhase 3
Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
Intensive Care Unit Delirium
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation After Cardiac Surgery, run by Medical University of Graz at 2 sites in Austria.
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 6 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of time spent in deep sedation (time frame: immediately after extubation or up to 48 hours of ICU sedation - whichever comes first). 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 21 Oct 2026.