Sex-Dependent Risk of Postoperative Delirium and Mediating Effects of Family Visits

Official title

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

Overview

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.

Primary outcome measures

• Postoperative Delirium [Time frame: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first.]

Secondary outcome measures (1)

• Family Visits [Time frame: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• Universitätsspital Zürich — Zurich

Identifiers

NCT: NCT07502391 · 2025-02296

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗