PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

NCT07612579 | Recruiting

• 1 other identifier: PROSEVO
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of postoperative delirium II

  01.01.2011 - 31.12.2025

• Delirium severity

  01.01.2011 - 31.12.2025

• Duration of delirium

  01.01.2011 - 31.12.2025

• Time to first occurrence of postoperative delirium

  01.01.2011 - 31.12.2025

• Length of hospital stay

  01.01.2011 - 31.12.2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

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

Berlin, 12203, Germany

RECRUITING

Department of Anesthesiology and Intensive Care Medicine Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)