PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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;

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
01.01.2011 - 31.12.2025

Secondary outcomes

1

Incidence of postoperative delirium II

Incidence of postoperative delirium specifically in the recovery room

Time frame
01.01.2011 - 31.12.2025
2

Delirium severity

Delirium severity according to the Delirium Detection Score (DDS)

Time frame
01.01.2011 - 31.12.2025
3

Duration of delirium

Number of days with positive delirium screening results

Time frame
01.01.2011 - 31.12.2025
4

Time to first occurrence of postoperative delirium

Time to first occurrence of delirium in days after surgery

Time frame
01.01.2011 - 31.12.2025

Other outcomes

Sponsors and contacts

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