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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05798767
Other study ID # PCI and POD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date March 1, 2023

Study information

Verified date January 2023
Source Henan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Preoperative cognitive impairment (PCI) may increase the incidence of postoperative delirium (POD), yet screening for cognitive impairment is rarely performed. This study hypothesized that Mini-Cog for preoperative cognitive impairment screening predicts postoperative delirium. Elderly patients (65 years or older) attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery were recruited into the study.


Description:

We collected data points on demographics and hospital episodes through the electronic medical record the day before surgery. 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, and the time spent on Mini-Cog test and MMSE assessment was recorded. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. 65 years of age or older, 2. elective thoracic surgery, 3. under general anesthesia. Exclusion Criteria: 1. history of psychiatric disorders, 2. use of any antipsychotic drugs, 3. ASA score >3 4. severe visual, hearing, or physical dysfunction unable to complete the scale 5. advanced malignant tumors of the chest with distant metastases to bone, liver, etc., 6. history of general anesthesia surgery in the last six months.

Study Design


Intervention

Behavioral:
Neuropsychological tests
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.

Locations

Country Name City State
China Henan People's Hospital Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary delirium postoperative delirium accessed by the Short Confusion Assessment Method (CAM) February 2022 to March 2023
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