Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

3. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Postoperativt delirium

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Claudia Spies, MD, Prof.
Telefonnummer: +49 30 450 55 11 02
E-post: claudia.spies@charite.de

Studiesteder

Tyskland
- - Berlin, Tyskland, 12203
    - Rekruttering
    - Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
    - Hovedetterforsker:
      
      Sascha Treskatsch, MD, Prof.
    - Ta kontakt med:
      
      Sascha Treskatsch, MD. Prof.
      
      Telefonnummer: +49 30 450 55 15 22
      
      E-post: sascha.treskatsch@charite.de
  - Berlin, Tyskland, 13353
    - Rekruttering
    - Department of Anesthesiology and Intensive Care Medicine Berlin
    - Hovedetterforsker:
      
      Claudia Spies, MD, Prof.
    - Ta kontakt med:
      
      Claudia Spies, MD, Prof.
    - Underetterforsker:
      
      Maximilian Markus, MD
    - Underetterforsker:
      
      Hannah Zoe Wurm
    - Underetterforsker:
      
      Nils Daum, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Incidence of postoperative delirium I Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Incidence of postoperative delirium II Tidsramme: 01.01.2011 - 31.12.2025	Incidence of postoperative delirium specifically in the recovery room	01.01.2011 - 31.12.2025
Delirium severity Tidsramme: 01.01.2011 - 31.12.2025	Delirium severity according to the Delirium Detection Score (DDS)	01.01.2011 - 31.12.2025
Duration of delirium Tidsramme: 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 Tidsramme: 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 Tidsramme: 01.01.2011 - 31.12.2025	Length of hospital stay in days	01.01.2011 - 31.12.2025
Unplanned intensive care unit admission Tidsramme: 01.01.2011 - 31.12.2025	Unplanned ICU admission by hospital records	01.01.2011 - 31.12.2025
30-day mortality Tidsramme: 01.01.2011 - 31.01.2026	30-day mortality by hospital records	01.01.2011 - 31.01.2026

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Etterforskere

Studieleder: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. juni 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene