Postoperative DeliriumNCT05572307
Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty
An observational study of Postoperative Delirium and Chronic Postsurgical Pain, run by Xuzhou Central Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium, Chronic Postsurgical Pain
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing elective total knee replacement.
Who may be able to join
- Age ≥65 years old, regardless of gender.
- total knee arthroplasty for the first time.
- The ASA classification is I-Ⅲ.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Yangzi Zhu, Doctor, +86 18168779150, zhuyz@188.com
About this study
Official title: Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty
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.
Read the detailed 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.
- Conditions
- Postoperative Delirium, Chronic Postsurgical Pain
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POD group | According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group | |
| non-POD group | According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group | |
| CPSP group | Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain | |
| non-CSP group | Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months after the surgery
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.
Measured: 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.
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start30 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Yangzi Zhu, Doctor, Principal investigator, Xuzhou Central HospitalLiwei Wang, Doctor, Study director, Xuzhou Central HospitalJunli Cao, Doctor, Study director, Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical UniversityDaqing Ma, Doctor, Study chair, Imperial College London, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572307
- Sponsor's protocol ID
- XuzhouCH20221010
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05572307
- Acronym / sponsor ID
- XuzhouCH20221010
- Conditions
- Postoperative Delirium, Chronic Postsurgical Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POD group | – | –According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group |
| non-POD group | – | –According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group |
| CPSP group | – | –Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain |
| non-CSP group | – | –Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective total knee replacement.
Key inclusion criteria (3 listed)
- Age ≥65 years old, regardless of gender.
- total knee arthroplasty for the first time.
- The ASA classification is I-Ⅲ.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of single cell sequencing before and after surgery
Time frame: 1 day before surgery，1 day 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
3-minute Diagnostic Interview for CAM (3D-CAM)
Time frame: Consecutive 7 days after the surgery
Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).
Visual analogue scale（VAS）
Time frame: 3 months after the surgery
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.
Short form McGill pain questionnaire（SF-MPQ）
Time frame: 3 months after the surgery
SF-MPQ is composed of sensory and emotional descriptors of pain, current pain intensity and visual analogue scale.
Leeds Assessment of Neuropathic Symptoms and Signs（LANSS）
Time frame: 3 months after the surgery
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.
Pain catastrophizing scale(PCS)
Time frame: 3 months after the surgery
PCS is defined as a belief system, a coping strategy and an evaluation process when experiencing and feeling pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangzi Zhu, Doctor principal investigator
Xuzhou Central Hospital
Liwei Wang, Doctor study director
Xuzhou Central Hospital
Junli Cao, Doctor study director
Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Chronic Postsurgical Pain, run by Xuzhou Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangzi Zhu, Doctor (+86 18168779150, zhuyz@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of single cell sequencing before and after surgery (time frame: 1 day before surgery，1 day after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.