NCT07744282

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 20, 2026

Last Update Submit

August 1, 2026

Conditions

Cohort Studies

Keywords

DepressionPostoperative DeliriumNon-cardiac major surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Delirium within 7 days of surgery

Secondary Outcomes (2)

  • Postoperative Acute Pain

    Pain within 7 days of surgery

  • Postoperative Pulmonary Infection

    Within 7 days of surgery

Study Arms (2)

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

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • \. 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)

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionEmergence Delirium

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Chen Cai

CONTACT

+86137187187811607125811@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

July 20, 2026

First Posted

August 4, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07