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.
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Claudia Spies, MD, Prof.
- 電話番号：+49 30 450 55 11 02
- メール：claudia.spies@charite.de
研究場所
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Berlin、ドイツ、12203
- 募集
- Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
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主任研究者：
- Sascha Treskatsch, MD, Prof.
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コンタクト：
- Sascha Treskatsch, MD. Prof.
- 電話番号：+49 30 450 55 15 22
- メール：sascha.treskatsch@charite.de
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Berlin、ドイツ、13353
- 募集
- Department of Anesthesiology and Intensive Care Medicine Berlin
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主任研究者：
- Claudia Spies, MD, Prof.
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コンタクト：
- Claudia Spies, MD, Prof.
-
副調査官：
- Maximilian Markus, MD
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副調査官：
- Hannah Zoe Wurm
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副調査官：
- Nils Daum, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
- 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
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of postoperative delirium I
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of postoperative delirium II
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Claudia Spies, MD, Prof.、Charite University, Berlin, Germany
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。