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PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

Key facts

Who runs it
Charite University, Berlin, Germany
Where
Germany2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
100,000 people, planned
Started
3 Jun 2026
Expected to end
Dec 2027
Type of study
Observational
Record updated
4 June 2026

Who can take part

Age
18 years and older
Sex
Women and men

The registry criteria, word for word

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Who can take part

  • 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 take part

  • neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms)
  • 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)
  • 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)
  • severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score <15 points, or
  • preoperatively documented severe dementia
  • Patients in any of the following situations are excluded:
  • 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
  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
4 June 2026