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NCT Number: NCT07744282

The Impact of Preoperative Depression on Postoperative Delirium in Elderly Chinese Patients: A Retrospective Multicenter Observational Study

This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of preoperative depression on the incidence of postoperative delirium among elderly Chinese patients undergoing non-cardiac major surgery.

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Key information

Conditions

Cohort Studies Behavior Behavioral Symptoms Confusion Delirium Depression Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

Preoperative depression is common among elderly surgical patients and may adversely affect postoperative outcomes. However, there is limited research on the relationship between preoperative depression and postoperative delirium (POD) in elderly patients undergoing non-cardiac major surgery. This study retrospectively analysed data from a prospective database (PDCEP) of patients aged 65 and above who underwent non-cardiac major elective surgery in multiple tertiary hospitals across 10 provinces in China. The study period spanned from April 1, 2020 to April 30, 2022.

Preoperative depression was assessed using the Patient Health Questionnaire-9 (PHQ-9), with PHQ-9 > 5 defined as the depression group and PHQ-9 < 5 as the non-depression group. Postoperative delirium was evaluated using the 3-minute Diagnostic Interview for CAM (3D-CAM). Binary logistic regression analyses were conducted, and propensity score-matching (PSM) and subgroup analyses were also applied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Age ≥ 65 years, both genders 2. Elective non-cardiac major surgery 3. Completed preoperative depression assessment (PHQ-9) 4. Completed postoperative delirium assessment (3D-CAM)

Exclusion criteria

  • 1. History of neurological or psychiatric disorders or use of neuropsychiatric medications 2. Impaired cognitive function or inability to complete preoperative follow-up 3. Transferred to ICU postoperatively 4. Missing delirium outcome data

Treatment and study plan

Primary outcomes

  1. Postoperative Delirium

    Time frame: Delirium within 7 days of surgery

    Postoperative delirium (POD) incidence was assessed using the 3-minute Diagnostic Interview for CAM (3D-CAM). The 3D-CAM is a validated tool for the detection of delirium in older adults. It evaluates four key features: acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. If the patient was discharged, follow-up was conducted by telephone or email.

Secondary outcomes

  1. Postoperative Acute Pain

    Time frame: Pain within 7 days of surgery

    Postoperative acute pain was assessed using the Numerical Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain).

  2. Postoperative Pulmonary Infection

    Time frame: Within 7 days of surgery

    Postoperative pulmonary infection was assessed through physical examination and laboratory tests (chest X-ray, white blood cell count, etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Cai

CONTACT

[email protected]

+8613718718781

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Tsinghua Changgeng Hospital
  • Central South University
  • China-Japan Friendship Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Fudan University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Sun Yat-sen University
  • Taihe Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital of Central South University
  • Zhejiang University

Registry information

Official study title

Preoperative Depression and Postoperative Delirium in Older Chinese Adults: A Multicenter Retrospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

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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