Cohort StudiesNCT07744282
The Impact of Preoperative Depression on Postoperative Delirium in Elderly Chinese Patients: A Retrospective Multicenter Observational Study
An observational study of Cohort Studies, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Cohort Studies
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (aged ≥ 65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Depression and Postoperative Delirium in Older Chinese Adults: A Multicenter Retrospective Cohort 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.
Read the 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.
- Conditions
- Cohort Studies
- Keywords
- Depression, Postoperative Delirium, Non-cardiac major surgery
- Medical subject headings
- Depression, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
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.
Measured: Delirium within 7 days of surgery
Secondary outcomes (2)
Postoperative Acute Pain
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).
Measured: Pain within 7 days of surgery
Postoperative Pulmonary Infection
Postoperative pulmonary infection was assessed through physical examination and laboratory tests (chest X-ray, white blood cell count, etc.).
Measured: Within 7 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cohort StudiesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744282
- Sponsor's protocol ID
- PLAGH-D-POD
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Depression and Postoperative Delirium in Older Chinese Adults: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07744282
- Acronym / sponsor ID
- PLAGH-D-POD
- Conditions
- Cohort Studies
- Keywords
- Depression, Postoperative Delirium, Non-cardiac major surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or 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
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (aged ≥ 65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Postoperative Acute Pain
Time frame: Pain within 7 days of surgery
Postoperative Pulmonary Infection
Time frame: Within 7 days of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cohort Studies, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Cai (+8613718718781, 1607125811@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: Delirium within 7 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.