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PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 12203
        • Rekruttering
        • Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
        • Ledende efterforsker:
          • Sascha Treskatsch, MD, Prof.
        • Kontakt:
      • Berlin, Tyskland, 13353
        • Rekruttering
        • Department of Anesthesiology and Intensive Care Medicine Berlin
        • Ledende efterforsker:
          • Claudia Spies, MD, Prof.
        • Kontakt:
          • Claudia Spies, MD, Prof.
        • Underforsker:
          • Maximilian Markus, MD
        • Underforsker:
          • Hannah Zoe Wurm
        • Underforsker:
          • Nils Daum, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

  • 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:

  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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PROSEVO

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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