- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07709975
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Zekeriya Ervatan, MD
- 전화번호: +90505 598 32 48
- 이메일: zek.ervatan@gmail.com
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34384
- 모병
- University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
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연락하다:
- Zekeriya Ervatan, MD
- 전화번호: +90505 598 32 48
- 이메일: zek.ervatan@gmail.com
-
연락하다:
- Beyzanur Aydoğdu, MD
- 전화번호: +90531 367 70 76
- 이메일: beyzaaydogan7714@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Systemic Analgesia
Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
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Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
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Epidural Analgesia
Patients who receive epidural analgesia as determined by the treating clinical team.
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Standard-of-care epidural analgesia administered per routine clinical practice.
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Peripheral Nerve Block
Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
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Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to First Mobilization
기간: From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
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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.
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From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Score
기간: At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
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Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
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At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
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Incidence of Delirium
기간: Assessed at least once daily for the first 3 days of ICU stay
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Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
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Assessed at least once daily for the first 3 days of ICU stay
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Length of ICU Stay
기간: From ICU admission to ICU discharge, up to approximately 30 days
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Total number of days the patient remains in the intensive care unit.
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From ICU admission to ICU discharge, up to approximately 30 days
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Total Opioid Consumption
기간: From ICU admission to ICU discharge, up to approximately 30 days
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Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
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From ICU admission to ICU discharge, up to approximately 30 days
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Patient Satisfaction with Analgesia
기간: Assessed once, prior to ICU discharge
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Patient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
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Assessed once, prior to ICU discharge
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Incidence and Type of Postoperative Complications
기간: From ICU admission to ICU discharge, up to approximately 30 days
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Presence and type of any postoperative complications recorded during ICU stay.
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From ICU admission to ICU discharge, up to approximately 30 days
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CT-ERHO-AR-BA-04
- E-48670771-514.99-316163880 (기타 식별자: University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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