- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06861764
The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients
March 18, 2025 updated by: Weidong Mi, Chinese PLA General Hospital
The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
Study Overview
Status
Completed
Conditions
Detailed Description
This is a retrospective cohort study using prospective data from a multicenter database.
8000 elderly patients undergoing elective non-cardiac or non-neurosurgical surgery were included in this study.
The Generalized Anxiety Disorder Scale (GAD-7) was used to measure preoperative anxiety symptoms.
The confusion assessment method (3D-CAM) was used to assess postoperative delirium in elderly patients undergoing non-cardiac surgery.
If the patient is discharged, follow up by phone or email.
Binary logistic regression analysis and propensity score matching (PSM) and subgroup analysis were used to analyze the data.
Study Type
Observational
Enrollment (Actual)
8000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Elderly patients (aged ≥ 65 years) who completed the anxiety assessment after the elective noncardiac, non-neurosurgical surgery were included in this study.
Description
Inclusion Criteria:
- elderly patients (age ≥ 65 years)
- non-cardiac surgery, non-neurosurgical surgery
Exclusion Criteria:
- History of neurological or psychiatric disorders or use of neuropsychiatric drugs;
- Impaired cognitive function or inability to cooperate with preoperative follow-up;
- Sent to ICU after surgery;
- Deletional delirium outcome;
- Baseline missing >5%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Preoperative anxiety
According to the GAD-7 scale, the population was defined as the Preoperative anxiety group
|
|
Non-preoperative anxiety
According to the GAD-7 scale, the population was defined as the Non-preoperative anxiety group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative delirium
Time Frame: within 7 days after surgery
|
The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).
|
within 7 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
March 1, 2025
First Submitted That Met QC Criteria
March 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 18, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-PA-PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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