Preoperative Cognitive Impairment Predicts Postoperative Delirium

Sponsor

Henan Provincial People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05798767

Collaborator

(none)

150

Enrollment

Location

12.9

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delirium in Old Age Neurocognitive Disorders Cognitive Impairment	Behavioral: Neuropsychological tests

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Preoperative Cognitive Impairment Predicts Postoperative Delirium in Elderly Patients Undergoing General Anesthesia

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
PCI group Patients with a Mini-Cog score of 3 or less were in the PCI group	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.
Normal group Patients with a Mini-Cog score of 3 or 4 were in the normal group	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.

Arm

Intervention/Treatment

PCI group

Patients with a Mini-Cog score of 3 or less were in the PCI group

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.

Normal group

Patients with a Mini-Cog score of 3 or 4 were in the normal group

Behavioral: Neuropsychological tests

Outcome Measures

Primary Outcome Measures

delirium [February 2022 to March 2023]
postoperative delirium accessed by the Short Confusion Assessment Method (CAM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan People's Hospital	Zhengzhou		China

Sponsors and Collaborators

Henan Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henan Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT05798767

Other Study ID Numbers:

PCI and POD

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Cognitive Dysfunction

Neurocognitive Disorders

Study Results

No Results Posted as of Apr 5, 2023