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PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07612579
Enrollment
100000
Registered
2026-05-28
Start date
2026-06-03
Completion date
2027-12-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Brief 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.

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative delirium I01.01.2011 - 31.12.2025The 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.

Secondary

MeasureTime frameDescription
Incidence of postoperative delirium II01.01.2011 - 31.12.2025Incidence of postoperative delirium specifically in the recovery room
Delirium severity01.01.2011 - 31.12.2025Delirium severity according to the Delirium Detection Score (DDS)
Duration of delirium01.01.2011 - 31.12.2025Number of days with positive delirium screening results
Time to first occurrence of postoperative delirium01.01.2011 - 31.12.2025Time to first occurrence of delirium in days after surgery
Length of hospital stay01.01.2011 - 31.12.2025Length of hospital stay in days
Unplanned intensive care unit admission01.01.2011 - 31.12.2025Unplanned ICU admission by hospital records
30-day mortality01.01.2011 - 31.01.202630-day mortality by hospital records

Countries

Germany

Contacts

CONTACTClaudia Spies, MD, Prof.
claudia.spies@charite.de+49 30 450 55 11 02
STUDY_DIRECTORClaudia Spies, MD, Prof.

Charite University, Berlin, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026