PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)
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.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Claudia Spies, MD, Prof.
- 전화번호: +49 30 450 55 11 02
- 이메일: claudia.spies@charite.de
연구 장소
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Berlin, 독일, 12203
- 모병
- Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
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수석 연구원:
- Sascha Treskatsch, MD, Prof.
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연락하다:
- Sascha Treskatsch, MD. Prof.
- 전화번호: +49 30 450 55 15 22
- 이메일: sascha.treskatsch@charite.de
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Berlin, 독일, 13353
- 모병
- Department of Anesthesiology and Intensive Care Medicine Berlin
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수석 연구원:
- Claudia Spies, MD, Prof.
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연락하다:
- Claudia Spies, MD, Prof.
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부수사관:
- Maximilian Markus, MD
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부수사관:
- Hannah Zoe Wurm
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부수사관:
- Nils Daum, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- 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
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of postoperative delirium I
기간: 01.01.2011 - 31.12.2025
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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.
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01.01.2011 - 31.12.2025
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of postoperative delirium II
기간: 01.01.2011 - 31.12.2025
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Incidence of postoperative delirium specifically in the recovery room
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01.01.2011 - 31.12.2025
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Delirium severity
기간: 01.01.2011 - 31.12.2025
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Delirium severity according to the Delirium Detection Score (DDS)
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01.01.2011 - 31.12.2025
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Duration of delirium
기간: 01.01.2011 - 31.12.2025
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Number of days with positive delirium screening results
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01.01.2011 - 31.12.2025
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Time to first occurrence of postoperative delirium
기간: 01.01.2011 - 31.12.2025
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Time to first occurrence of delirium in days after surgery
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01.01.2011 - 31.12.2025
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Length of hospital stay
기간: 01.01.2011 - 31.12.2025
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Length of hospital stay in days
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01.01.2011 - 31.12.2025
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Unplanned intensive care unit admission
기간: 01.01.2011 - 31.12.2025
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Unplanned ICU admission by hospital records
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01.01.2011 - 31.12.2025
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30-day mortality
기간: 01.01.2011 - 31.01.2026
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30-day mortality by hospital records
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01.01.2011 - 31.01.2026
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공동 작업자 및 조사자
수사관
- 연구 책임자: Claudia Spies, MD, Prof., Charite University, Berlin, Germany
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .