PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Incidence of postoperative delirium I [Time frame: 01.01.2011 - 31.12.2025]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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:
- 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)
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 2 centers
- Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedi — Berlin
- Department of Anesthesiology and Intensive Care Medicine Berlin — Berlin
Identifiers
NCT: NCT07612579 · PROSEVO