Propofol vs Sevoflurane Delirium in Postoperative Patients: A Large Look Back at Anesthesia Choices
Official title: PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)
Run by Charite University, Berlin, Germany · NCT07612579 · Data updated 2026-11-12
This study tests whether the choice of anesthesia technique during elective surgery affects the risk of delirium after surgery in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100000 (estimated) |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 2 sites (Berlin and 1 other locations) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07612579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older undergoing elective general anesthesia with surgery planned to last at least 30 minutes at Charité, not having had delirium before surgery.
✕Probably not a fit
Patients undergoing cardiac surgery or those with preoperative delirium would be less likely to benefit from findings related to general anesthesia practices.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective, single-center cohort study using routine data from Charité – Universitätsmedizin Berlin and partners, spanning 2011 through 2026. It analyzes adult patients undergoing elective general anesthesia with a planned minimum surgery time of 30 minutes, excluding cardiac surgeries and those with preexisting delirium. The goal is to compare different anesthetic techniques (e.g., propofol vs sevoflurane) and their association with postoperative delirium, informing future guidelines in this area. The study design emphasizes observational associations rather than randomized testing, with data drawn from real-world clinical records across the hospital network. Findings could influence anesthesia practice guidelines if a technique is linked to lower delirium risk.
Why it matters
Potential benefit: If a specific anesthetic technique is linked to lower delirium risk, hospitals may adjust protocols to reduce delirium and its associated harms.
How similar studies have gone: Previous observational work has explored anesthesia-technique associations with delirium, but large, adequately powered comparative evidence remains limited, making this study a meaningful contribution.
Who can join: the full rules
Show full inclusion / exclusion 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: 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)
Where it's running
-
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
Study contacts
- Study coordinator: Claudia Spies, MD, Prof.
- Email: claudia.spies@charite.de
- Phone: +49 30 450 55 11 02
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.