Perioperative Neurocognitive DysfunctionNCT06044207
Biomarkers and Risk Factors for Perioperative Neurocognitive Dysfunction in Elderly Patients
An observational study of Perioperative Neurocognitive Dysfunction, run by Jinan Central Hospital at 1 site in China.
Trial summary
Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Neurocognitive Dysfunction
- What is being tested?
- Pittsburgh sleep quality index, Self-rating depression scale and Montreal Cognitive Assessment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly people older than 65 years old who have been identified for non-neurosurgical procedures at Jinan Central Hospital
Who may be able to join
- Age more than or equal to 65 years old
- ASA classification Ⅰ~Ⅲ grade
Who cannot join
- History of previous Craniocerebral surgery or Craniocerebral trauma
- Inability to successfully complete preoperative psychological function tests
- Those who are severely deaf, speech impaired and otherwise unable to communicate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250000
Wenying Chi, Master, 18654557772, cwy2907@zxyy.cn
About this study
Official title: Biomarkers and Risk Factors for Perioperative Neurocognitive Disorders in Elderly Non-neurosurgical Patients
Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and statistically processing basic information and biological samples.
- Conditions
- Perioperative Neurocognitive Dysfunction
- Being tested
- Pittsburgh sleep quality index, Self-rating depression scale, Montreal Cognitive Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh sleep quality indexDiagnostic test
The scale is suitable for evaluating sleep quality in patients with sleep disorders and psychiatric disorders, as well as for assessing sleep quality in the general population.
Self-rating depression scaleDiagnostic test
The scale is easy to use, can fairly intuitively reflect whether the patient has depression and the degree of depression, has been widely used in outpatient gross screening, mood state assessment.
Montreal Cognitive AssessmentDiagnostic test
The scale is a tool used for rapid screening of mild cognitive dysfunction to identify patients with preoperative cognitive dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Patients with perioperative neurocognitive dysfunction | Not described Receives: Diagnostic Test: Pittsburgh sleep quality index; Diagnostic Test: Self-rating depression scale; Diagnostic Test: Montreal Cognitive Assessment | |
| Patients without perioperative neurocognitive dysfunction | Not described Receives: Diagnostic Test: Pittsburgh sleep quality index; Diagnostic Test: Self-rating depression scale; Diagnostic Test: Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative neurocognitive dysfunction
Identification of patients who develop perioperative neurocognitive disorders after surgery by postoperative follow-up with cognitive function tests
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Neurocognitive DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044207
- Sponsor's protocol ID
- 2023-076-01
- Status last verified
- May 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Risk Factors for Perioperative Neurocognitive Disorders in Elderly Non-neurosurgical Patients
- ClinicalTrials.gov ID
- NCT06044207
- Acronym / sponsor ID
- 2023-076-01
- Conditions
- Perioperative Neurocognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jinan Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and statistically processing basic information and biological samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with perioperative neurocognitive dysfunction | – | Diagnostic Test: Pittsburgh sleep quality index, Diagnostic Test: Self-rating depression scale, Diagnostic Test: Montreal Cognitive Assessment |
| Patients without perioperative neurocognitive dysfunction | – | Diagnostic Test: Pittsburgh sleep quality index, Diagnostic Test: Self-rating depression scale, Diagnostic Test: Montreal Cognitive Assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly people older than 65 years old who have been identified for non-neurosurgical procedures at Jinan Central Hospital
Key inclusion criteria (2 listed)
- Age more than or equal to 65 years old
- ASA classification Ⅰ~Ⅲ grade
Key exclusion criteria (3 listed)
- History of previous Craniocerebral surgery or Craniocerebral trauma
- Inability to successfully complete preoperative psychological function tests
- Those who are severely deaf, speech impaired and otherwise unable to communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pittsburgh sleep quality indexThe scale is suitable for evaluating sleep quality in patients with sleep disorders and psychiatric disorders, as well as for assessing sleep quality in the general population. | Diagnostic test | Patients with perioperative neurocognitive dysfunction, Patients without perioperative neurocognitive dysfunction |
| Self-rating depression scaleThe scale is easy to use, can fairly intuitively reflect whether the patient has depression and the degree of depression, has been widely used in outpatient gross screening, mood state assessment. | Diagnostic test | Patients with perioperative neurocognitive dysfunction, Patients without perioperative neurocognitive dysfunction |
| Montreal Cognitive AssessmentThe scale is a tool used for rapid screening of mild cognitive dysfunction to identify patients with preoperative cognitive dysfunction | Diagnostic test | Patients with perioperative neurocognitive dysfunction, Patients without perioperative neurocognitive dysfunction |
Primary outcome
Perioperative neurocognitive dysfunction
Time frame: 1 year postoperative
Identification of patients who develop perioperative neurocognitive disorders after surgery by postoperative follow-up with cognitive function tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
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 Perioperative Neurocognitive Dysfunction, run by Jinan 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 2 inclusion and 3 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 21 Sep 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 Wenying Chi, Master (18654557772, cwy2907@zxyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative neurocognitive dysfunction (time frame: 1 year postoperative). 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 21 Sep 2023.