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临床试验/NCT07709975
NCT07709975招募中不适用

Effect of Analgesia Methods on Early Mobilization and Patient Satisfaction in Geriatric Patients Admitted to Intensive Care After Major Surgery

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年6月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Time to First Mobilization

研究概览

简要总结

This study looks at how different pain-control methods affect how quickly older adults get out of bed and start moving again after major surgery. Researchers will observe patients aged 65 and older who are admitted to the intensive care unit (ICU) after major surgery. Doctors will use their usual pain-control methods - either medication given through a vein, an epidural, or a nerve block - based on standard clinical practice; the study team will not change or choose the treatment. The study will record how long it takes for each patient to first sit up, stand, or walk after surgery, along with pain levels, confusion (delirium), how satisfied patients are with their pain control, and how long they stay in the ICU. The goal is to better understand which pain-control approaches may help older patients recover and move more quickly and safely after major surgery.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Time to First Mobilization

时间窗: 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.

次要结局

  • Postoperative Pain Score(At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission)
  • Incidence of Delirium(Assessed at least once daily for the first 3 days of ICU stay)
  • Length of ICU Stay(From ICU admission to ICU discharge, up to approximately 30 days)
  • Total Opioid Consumption(From ICU admission to ICU discharge, up to approximately 30 days)
  • Patient Satisfaction with Analgesia(Assessed once, prior to ICU discharge)
  • Incidence and Type of Postoperative Complications(From ICU admission to ICU discharge, up to approximately 30 days)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyzanur Aydoğdu

Specialist Physician

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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