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临床试验/NCT07502391
NCT07502391招募中不适用

Sex-Dependent Risk of Postoperative Delirium and Mediating Effects of Family Visits: A Prospective Observational Study

Julian Rössler1 个研究点 分布在 1 个国家目标入组 471 人开始时间: 2026年5月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
471
试验地点
1

研究概览

简要总结

Postoperative delirium is a common and serious complication after surgery, affecting 10-40% of older patients undergoing non-cardiac procedures. It is characterized by sudden changes in attention, awareness, and thinking that fluctuate throughout the day. Delirium is associated with longer hospital stays, higher mortality, worse long-term brain function, and substantially increased healthcare costs. While several risk factors are known, it remains unclear whether a patient's sex independently influences the risk of developing postoperative delirium, as existing studies have produced conflicting results and were often not designed to specifically examine sex differences.Family visitation is a promising non-drug approach to preventing delirium. Studies in intensive care patients have shown that those who receive family visits have a significantly lower risk of developing delirium. However, it is unknown whether men and women receive different amounts of family visits after surgery, and whether any such difference could help explain sex-based disparities in delirium risk. Given that traditional gender roles in caregiving persist, women - who often serve as primary caregivers in their families - may receive fewer visits when they themselves become patients.This prospective observational study led by the University of Zurich will enroll 471 patients aged 65 years or older undergoing non-cardiac surgery lasting at least 2 hours under general or spinal anesthesia. The primary aim is to determine whether female patients have a higher risk of developing postoperative delirium within three days after surgery compared to male patients. Delirium will be assessed twice daily using the 4 A's Test (4AT), a validated and standardized screening tool. The secondary aim is to evaluate whether female patients receive fewer family visits than male patients and whether any difference in visitation mediates the sex-dependent delirium risk. Family visits will be recorded using an anonymous sign-in sheet placed in the patient's room. The study does not involve any experimental interventions; all patients receive standard clinical care. Participation is voluntary, and withdrawal is possible at any time without affecting medical treatment.

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

  • Informed consent as documented by signature;
  • ≥65 years of age;
  • Scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours;
  • Under either general or spinal anesthesia.

排除标准

  • Known drug or alcohol abuse;
  • Requirement for postoperative ventilation;
  • Current participation in another study with an investigational drug;
  • Inability to complete the study assessments.

研究者

发起方
Julian Rössler
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julian Rössler

Attending Physician, Institute of Anesthesiology and Perioperative Medicine

University of Zurich

研究点 (1)

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