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Clinical Trials in Germany / NCT07612579
Recruiting Observational

PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

NCT07612579 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2026-06-03
Last updated
2026-06-04

Condition(s) studied

Postoperative Delirium

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: Patients in any of the following situations are excluded: 1. 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) 2. 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; 3. severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \<15 points, or 4. preoperatively documented severe dementia 5. neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms) 6. 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) 7. Patients who were already intubated or sedated prior to surgery (this group cannot undergo standardized POD screening) 8. 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)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Department of Anesthesiology and Intensive Care Medicine Berlin Berlin Germany Recruiting

More Charite University, Berlin, Germany trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612579 on ClinicalTrials.gov ↗ ← All trials in Germany