Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty

Postoperative Delirium Clinical Trial

Official title:

Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572307
• Other study ID #: XuzhouCH20221010
• Status: Recruiting
• Start date: October 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Xuzhou Central Hospital
• Contact: Yangzi Zhu, Doctor
• Phone: +86 18168779150
• Email: zhuyz[@]188.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-celled sequencing for evaluating differences in gene expression patterns in different cell types of the dynamics of a means of this research as a starting point, to study the postoperative delirium and chronic pain at the cellular level changes the contents of a cell, reveal its occurrence and development of the role of gene regulation, find targets and biomarkers, and to provide new ideas for its pathogenesis, To provide theoretical basis support for its prevention, clinical diagnosis and treatment.

Description:

The aim of this study was to investigate leukocyte heterogeneity in patients undergoing total knee arthroplasty with POD, paired non-POD patients, and cognitively normal healthy subjects by single cell sequencing, and to investigate leukocyte heterogeneity in patients with chronic pain and patients with pain relief after surgery through postoperative pain follow-up. Moreover, multi-omics single cell technology is used to analyze various cellular contents in a single cell simultaneously, which can capture molecular footprints with higher resolution. Comprehensive analysis of multiple omics datasets reveals the relationships between cellular patterns, establishes complex regulatory networks, and provides a holistic view of cellular state. From a single cell level analysis of POD and occurred in patients with chronic pain in patients with the characteristics of the white blood cells, looking for the peripheral immune system in the pathogenesis of the POD and the potential role of chronic pain occurs, may provide POD pathogenesis and chronic pain occurred an important visual Angle, may also help to provide POD biomarkers and therapeutic targets, To provide a possible solution for the prevention and treatment of postoperative delirium and postoperative chronic pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =65 years old, regardless of gender.
• total knee arthroplasty for the first time.
• The ASA classification is I-?.

Exclusion Criteria:

• severe neurological or psychiatric disorders
• drug and alcohol abuse
• patients on antidepressants
• failure and decompensation of vital organs
• chronic pain from previous surgery or trauma

Related Conditions & MeSH terms

• Chronic Postsurgical Pain
• Delirium
• Pain, Postoperative
• Postoperative Delirium

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Xuzhou Central Hospital	The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of single cell sequencing before and after surgery	Leukocytes were isolated from peripheral blood and then sorted for subsequent single-cell sequencing analysis. Unbiased, high-throughput and high-resolution transcriptome analysis of single cells can reveal the gene structure and gene expression status of single cells, reflect the heterogeneity between cells, classify and analyze them, and carry out personalized research	1 day before surgery,1 day after surgery
Primary	3-minute Diagnostic Interview for CAM (3D-CAM)	Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).	Consecutive 7 days after the surgery
Primary	Visual analogue scale(VAS)	A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured.	3 months after the surgery
Primary	Short form McGill pain questionnaire(SF-MPQ)	SF-MPQ is composed of sensory and emotional descriptors of pain, current pain intensity and visual analogue scale.	3 months after the surgery
Primary	Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)	Make the needle perpendicular to the patient's skin, and apply different pressure on the skin to determine whether the patient has touch-induced pain.	3 months after the surgery
Primary	Pain catastrophizing scale(PCS)	PCS is defined as a belief system, a coping strategy and an evaluation process when experiencing and feeling pain.	3 months after the surgery