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

NCT07744282 — Not yet recruiting, 8000 participants, Chinese PLA General Hospital

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

Registry	NCT07744282
Status	Not yet recruiting
Study type	Observational
Enrollment	8000 (Estimated)
Sponsor	Chinese PLA General Hospital (Other); collaborators: Beijing Tsinghua Changgeng Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital
Conditions	Cohort Studies
Dates	start 2026-08-15 (estimated), primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-08-04, last updated 2026-08-04

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Depression group			Patients with PHQ-9 scores greater than 5, indicating mild to severe depressive symptoms before surgery.
Non-depression group			Patients with PHQ-9 scores less than 5, indicating minimal or no depressive symptoms before surgery

+Outcome measures

Primary outcomes

Postoperative Delirium [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

Postoperative Acute Pain [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).
Postoperative Pulmonary Infection [Within 7 days of surgery]: Postoperative pulmonary infection was assessed through physical examination and laboratory tests (chest X-ray, white blood cell count, etc.).

+Eligibility

Sex: All, ages: 65 Years to 100 Years

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