Analgesia Methods and Early Mobilization in Geriatric ICU Patients After Major Surgery
Effect of Analgesia Methods on Early Mobilization and Patient Satisfaction in Geriatric Patients Admitted to Intensive Care After Major Surgery
調査の概要
状態
詳細な説明
Early mobilization is a key component of enhanced postoperative recovery in older adults and has been associated with reduced functional decline, shorter intensive care unit (ICU) and hospital stays, and fewer postoperative complications. However, postoperative pain remains one of the main barriers to early mobilization. Although several analgesic strategies are routinely used after major surgery, their comparative effects on functional recovery in critically ill geriatric patients have not been well established in real-world clinical practice.
This is a prospective, single-center observational cohort study designed to evaluate the association between routinely administered postoperative analgesic techniques and early postoperative recovery in geriatric surgical patients requiring ICU admission. Because the study is observational, all perioperative and postoperative management, including the choice of analgesic technique, will be determined exclusively by the treating clinicians according to institutional practice. No treatment allocation, randomization, or protocol-driven intervention will be performed.
Clinical and perioperative data will be collected prospectively from routine medical records, anesthesia documentation, ICU electronic records, and nursing charts using standardized case report forms. Data quality will be ensured through predefined data collection procedures and verification before database entry. The study does not require any additional diagnostic tests, invasive procedures, blood sampling, or alterations to routine patient care.
The findings are expected to provide real-world evidence regarding the relationship between commonly used postoperative analgesic strategies and recovery after major surgery in older adults. These results may help optimize perioperative pain management protocols and support future comparative and interventional studies aimed at improving functional recovery in the geriatric surgical population.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zekeriya Ervatan, MD
- 電話番号：+90505 598 32 48
- メール：zek.ervatan@gmail.com
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）、34384
- 募集
- University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
-
コンタクト：
- Zekeriya Ervatan, MD
- 電話番号：+90505 598 32 48
- メール：zek.ervatan@gmail.com
-
コンタクト：
- Beyzanur Aydoğdu, MD
- 電話番号：+90531 367 70 76
- メール：beyzaaydogan7714@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 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
説明
Inclusion Criteria:
- Age 65 years or older
- ASA physical status classification I-IV
- Admitted to the intensive care unit (ICU) following major surgery
- ICU stay of at least 24 hours
Exclusion Criteria:
- Previously diagnosed advanced-stage dementia
- Inability to assess consciousness due to severe neurological deficit
- ICU stay of less than 24 hours
- Incomplete or insufficient clinical data
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Systemic Analgesia
Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
|
Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
|
|
Epidural Analgesia
Patients who receive epidural analgesia as determined by the treating clinical team.
|
Standard-of-care epidural analgesia administered per routine clinical practice.
|
|
Peripheral Nerve Block
Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
|
Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
|
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 |
|---|---|---|
|
Time to First Mobilization
時間枠：From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
|
Time (in hours) from ICU admission to the first time the patient achieves at least one level of mobilization - sitting at the bedside, standing, or walking - based on the ICU Mobility Scale.
|
From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Score
時間枠：At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
|
Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
|
At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
|
|
Incidence of Delirium
時間枠：Assessed at least once daily for the first 3 days of ICU stay
|
Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
|
Assessed at least once daily for the first 3 days of ICU stay
|
|
Length of ICU Stay
時間枠：From ICU admission to ICU discharge, up to approximately 30 days
|
Total number of days the patient remains in the intensive care unit.
|
From ICU admission to ICU discharge, up to approximately 30 days
|
|
Total Opioid Consumption
時間枠：From ICU admission to ICU discharge, up to approximately 30 days
|
Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
|
From ICU admission to ICU discharge, up to approximately 30 days
|
|
Patient Satisfaction with Analgesia
時間枠：Assessed once, prior to ICU discharge
|
Patient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
|
Assessed once, prior to ICU discharge
|
|
Incidence and Type of Postoperative Complications
時間枠：From ICU admission to ICU discharge, up to approximately 30 days
|
Presence and type of any postoperative complications recorded during ICU stay.
|
From ICU admission to ICU discharge, up to approximately 30 days
|
協力者と研究者
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CT-ERHO-AR-BA-04
- E-48670771-514.99-316163880 (その他の識別子：University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。