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Completed

NCT Number: NCT07259850

Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients

Postoperative delirium (POD) is a frequent complication in older surgical patients and is associated with adverse outcomes, while frailty is also highly prevalent during the perioperative period. This study aimed to determine whether POD accelerates perioperative frailty worsening and to assess the effect of their coexistence on 1-year mortality.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years;
  • Scheduled for elective non-cardiac, non-neurosurgical procedures;
  • Consented to undergo preoperative health and functional state assessments.

Exclusion criteria

  • Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
  • Had Mini-Mental State Examination (MMSE) scores below the established educational thresholds: <18 for illiterate individuals, <21 for those with primary education (≤6 years), and <25 for those with secondary education or higher (>6 years)
  • Underwent local anesthesia or monitored anesthesia care;
  • Had an operative time ≤30 minutes;
  • Incomplete preoperative FRAIL scale assessment;
  • Missing postoperative delirium data;
  • Incomplete FRAIL scale assessment at 1 month postoperatively.

Treatment and study plan

Primary outcomes

  1. The primary outcome was worsened frailty at one month after surgery.

    Time frame: At one month after surgery.

    Frailty was assessed preoperatively by trained researchers using the FRAIL scale, which includes five items: fatigue, resistance, ambulation, illnesses, and weight loss. Each item scores 0 or 1, for a total of 0-5 points, with higher scores indicating greater frailty. Patients were categorized as robust (0), pre-frail (1-2), or frail (3-5). A follow-up frailty assessment was conducted one month postoperatively via telephone. Frailty change was defined as the difference between postoperative and preoperative scores: ≤0 indicated stable/improved frailty, and >0 indicated worsened frailty.

Secondary outcomes

  1. The secondary outcome was 1-year all-cause mortality.

    Time frame: At one year after surgery.

    A structured telephone follow-up was conducted one year after surgery to determine outcomes.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients: A Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 2, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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