PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium

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.

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
    • Principal Investigator: Sascha Treskatsch, MD, Prof.
    • Contact: Sascha Treskatsch, MD. Prof.; Phone Number: +49 30 450 55 15 22; Email: sascha.treskatsch@charite.de
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Anesthesiology and Intensive Care Medicine Berlin
    • Principal Investigator: Claudia Spies, MD, Prof.
    • Contact: Claudia Spies, MD, Prof.
    • Sub-Investigator: Maximilian Markus, MD
    • Sub-Investigator: Hannah Zoe Wurm
    • Sub-Investigator: Nils Daum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium I	The 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.	01.01.2011 - 31.12.2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium II	Incidence of postoperative delirium specifically in the recovery room	01.01.2011 - 31.12.2025
Delirium severity	Delirium severity according to the Delirium Detection Score (DDS)	01.01.2011 - 31.12.2025
Duration of delirium	Number of days with positive delirium screening results	01.01.2011 - 31.12.2025
Time to first occurrence of postoperative delirium	Time to first occurrence of delirium in days after surgery	01.01.2011 - 31.12.2025
Length of hospital stay	Length of hospital stay in days	01.01.2011 - 31.12.2025
Unplanned intensive care unit admission	Unplanned ICU admission by hospital records	01.01.2011 - 31.12.2025
30-day mortality	30-day mortality by hospital records	01.01.2011 - 31.01.2026

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: PROSEVO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No