Postoperative DeliriumNCT07612579
PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The results of this study have significant implications for clinical practice and guideline development. The current European guideline on postoperative Delirium prevention (ESAIC 2024) explicitly identifies a lack of large, adequately powered studies comparing different anesthetic techniques and is therefore… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 100,000 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Jun 2026to Dec 2027
- Phase
- Observational
- 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
- Adult, Older adult
Study population: * Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité, * undergoing elective surgery under general anesthesia * with a planned surgery duration of ≥ 30 minutes
Who may be able to join
- Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité,
- undergoing elective surgery under general anesthesia
- with a planned surgery duration of ≥ 30 minutes
- In addition, the following conditions must be met:
- The surgery must be the patient's first surgery per hospital stay to avoid dependencies and repeated measurements of the same person within a short time frame;
- The surgeries take place at Charité between January 1, 2011, and December 31, 2025.
Who cannot join
- Patients in any of the following situations are excluded:
- Cardiac surgery (this patient group requires specialized monitoring strategies and has postoperative delirium risk profiles that differ significantly from those of other types of surgery)
- preoperatively diagnosed delirium, defined as positive results on the Nursing Delirium Screening Scale (NU-DESC) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during preoperative evaluations;
- severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score <15 points, or
- preoperatively documented severe dementia
- neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms)
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- Patients who were already admitted to intensive care units prior to their elective surgery (these patients already have increased mortality and a different risk profile)
- Patients who were already intubated or sedated prior to surgery (this group cannot undergo standardized POD screening)
- High preoperative risk for postoperative nausea and vomiting (PONV) (specifically, patients with documented PONV grade 3 or PONV grade 4 risk are excluded, as this group is indicated for anesthesia with propofol)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, 12203
Sascha Treskatsch, MD. Prof., +49 30 450 55 15 22, sascha.treskatsch@charite.de
Sascha Treskatsch, MD, Prof.
- Recruiting
Department of Anesthesiology and Intensive Care Medicine Berlin
Berlin, 13353
Claudia Spies, MD, Prof.
Claudia Spies, MD, Prof.
About this study
The results of this study have significant implications for clinical practice and guideline development. The current European guideline on postoperative Delirium prevention (ESAIC 2024) explicitly identifies a lack of large, adequately powered studies comparing different anesthetic techniques and is therefore currently unable to provide clear recommendations on the selection of an optimal technique. This study will close this knowledge gap and thus support future guideline recommendations. The results could show that a particular anesthetic technique (e.g., propofol) is associated with a significantly lower risk of postoperative delirium; if so, this would have immediate implications for modifying standard anesthesia protocols in hospitals.
Furthermore, Delirium is a significant public health challenge in aging societies. With demographic aging, the number of older patients undergoing surgery is continuously increasing. The societal costs of Delirium are estimated at several billion euros per year in major industrialized nations. A reduction in the incidence of postoperative Delirium by just 10% through optimization of the anesthetic procedure would therefore have major health economic implications.
Read the detailed description
This retrospective, single-center cohort study analyzes routine data from Charité - Universitätsmedizin Berlin and its clinical partners for the period from January 1, 2011, to January 31, 2026.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium I
The occurrence of postoperative delirium (yes/no) within the 5-day follow-up period, defined as a positive NU-DESC or CAM-ICU test result on at least one day of hospitalization.
Measured: 01.01.2011 - 31.12.2025
Secondary outcomes (7)
Incidence of postoperative delirium II
Incidence of postoperative delirium specifically in the recovery room
Measured: 01.01.2011 - 31.12.2025
Delirium severity
Delirium severity according to the Delirium Detection Score (DDS)
Measured: 01.01.2011 - 31.12.2025
Duration of delirium
Number of days with positive delirium screening results
Measured: 01.01.2011 - 31.12.2025
Time to first occurrence of postoperative delirium
Time to first occurrence of delirium in days after surgery
Measured: 01.01.2011 - 31.12.2025
Length of hospital stay
Length of hospital stay in days
Measured: 01.01.2011 - 31.12.2025
Unplanned intensive care unit admission
Unplanned ICU admission by hospital records
Measured: 01.01.2011 - 31.12.2025
30-day mortality
30-day mortality by hospital records
Measured: 01.01.2011 - 31.01.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start3 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612579
- Sponsor's protocol ID
- PROSEVO
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)
- ClinicalTrials.gov ID
- NCT07612579
- Acronym / sponsor ID
- PROSEVO
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 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.
The results of this study have significant implications for clinical practice and guideline development. The current European guideline on postoperative Delirium prevention (ESAIC 2024) explicitly identifies a lack of large, adequately powered studies comparing different anesthetic techniques and is therefore currently unable to provide clear recommendations on the selection of an optimal technique. This study will close this knowledge gap and thus support future guideline recommendations. The results could show that a particular anesthetic technique (e.g., propofol) is associated with a significantly lower risk of postoperative delirium; if so, this would have immediate implications for modifying standard anesthesia protocols in hospitals.
Furthermore, Delirium is a significant public health challenge in aging societies. With demographic aging, the number of older patients undergoing surgery is continuously increasing. The societal costs of Delirium are estimated at several billion euros per year in major industrialized nations. A reduction in the incidence of postoperative Delirium by just 10% through optimization of the anesthetic procedure would therefore have major health economic implications.
Detailed description
This retrospective, single-center cohort study analyzes routine data from Charité - Universitätsmedizin Berlin and its clinical partners for the period from January 1, 2011, to January 31, 2026.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité, * undergoing elective surgery under general anesthesia * with a planned surgery duration of ≥ 30 minutes
Key inclusion criteria (6 listed)
- Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité,
- undergoing elective surgery under general anesthesia
- with a planned surgery duration of ≥ 30 minutes
- The surgery must be the patient's first surgery per hospital stay to avoid dependencies and repeated measurements of the same person within a short time frame;
- The surgeries take place at Charité between January 1, 2011, and December 31, 2025.
Key exclusion criteria (9 listed)
- Cardiac surgery (this patient group requires specialized monitoring strategies and has postoperative delirium risk profiles that differ significantly from those of other types of surgery)
- preoperatively diagnosed delirium, defined as positive results on the Nursing Delirium Screening Scale (NU-DESC) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during preoperative evaluations;
- severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score <15 points, or
- preoperatively documented severe dementia
- neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms)
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
Incidence of postoperative delirium I
Time frame: 01.01.2011 - 31.12.2025
The occurrence of postoperative delirium (yes/no) within the 5-day follow-up period, defined as a positive NU-DESC or CAM-ICU test result on at least one day of hospitalization.
7 secondary outcomes
Incidence of postoperative delirium II
Time frame: 01.01.2011 - 31.12.2025
Delirium severity
Time frame: 01.01.2011 - 31.12.2025
Duration of delirium
Time frame: 01.01.2011 - 31.12.2025
Time to first occurrence of postoperative delirium
Time frame: 01.01.2011 - 31.12.2025
Length of hospital stay
Time frame: 01.01.2011 - 31.12.2025
Unplanned intensive care unit admission
Time frame: 01.01.2011 - 31.12.2025
30-day mortality
Time frame: 01.01.2011 - 31.01.2026
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 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 Postoperative Delirium, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Jun 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 Germany. 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?
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 Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium I (time frame: 01.01.2011 - 31.12.2025). 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 4 Jun 2026.