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PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

3 juin 2026 mis à jour par: Claudia Spies, Charite University, Berlin, Germany

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Délire postopératoire

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

100000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Claudia Spies, MD, Prof.
Numéro de téléphone: +49 30 450 55 11 02
E-mail: claudia.spies@charite.de

Lieux d'étude

Allemagne
- - Berlin, Allemagne, 12203
    - Recrutement
    - Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
    - Chercheur principal:
      
      Sascha Treskatsch, MD, Prof.
    - Contact:
      
      Sascha Treskatsch, MD. Prof.
      
      Numéro de téléphone: +49 30 450 55 15 22
      
      E-mail: sascha.treskatsch@charite.de
  - Berlin, Allemagne, 13353
    - Recrutement
    - Department of Anesthesiology and Intensive Care Medicine Berlin
    - Chercheur principal:
      
      Claudia Spies, MD, Prof.
    - Contact:
      
      Claudia Spies, MD, Prof.
    - Sous-enquêteur:
      
      Maximilian Markus, MD
    - Sous-enquêteur:
      
      Hannah Zoe Wurm
    - Sous-enquêteur:
      
      Nils Daum, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La 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:

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Incidence of postoperative delirium I Délai: 01.01.2011 - 31.12.2025	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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Charite University, Berlin, Germany

Les enquêteurs

Directeur d'études: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 juin 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité