NCT05572307|UnknownDMC
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Sponsor study identifier
observational
10
1 country
1
Study Start
October 30, 2022
Actual (reported)Primary Completion
October 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2022
Actual (reported)October 7, 2022
Actual (reported)October 30, 2022
Actual (reported)October 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain
Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain
Patients undergoing elective total knee replacement.
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Nucleated cells from peripheral blood were extracted and frozen.These cells are destroyed after single-cell sequencing.
Yangzi Zhu, Doctor
Xuzhou Central Hospital
Liwei Wang, Doctor
Xuzhou Central Hospital
Junli Cao, Doctor
Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University
Daqing Ma, Doctor
Imperial College London, Chelsea and Westminster Hospital
First Submitted
September 29, 2022
First Posted
October 7, 2022
Study Start
October 30, 2022
Actual (reported)Primary Completion
October 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Biomarkers and Postoperative Delirium in Elderly Patients
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
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
Contact the study team to confirm eligibility.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 8, 2023
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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