- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798767
Preoperative Cognitive Impairment Predicts Postoperative Delirium
Preoperative Cognitive Impairment Predicts Postoperative Delirium in Elderly Patients Undergoing General Anesthesia
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zhengzhou, China
- Henan People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years of age or older,
- elective thoracic surgery,
- under general anesthesia.
Exclusion Criteria:
- history of psychiatric disorders,
- use of any antipsychotic drugs,
- ASA score >3
- severe visual, hearing, or physical dysfunction unable to complete the scale
- advanced malignant tumors of the chest with distant metastases to bone, liver, etc.,
- history of general anesthesia surgery in the last six months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PCI group
Patients with a Mini-Cog score of 3 or less were in the PCI group
|
Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed the day before surgery. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium. |
|
Normal group
Patients with a Mini-Cog score of 3 or 4 were in the normal group
|
Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed the day before surgery. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delirium
Time Frame: February 2022 to March 2023
|
postoperative delirium accessed by the Short Confusion Assessment Method (CAM)
|
February 2022 to March 2023
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCI and POD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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