POCD - Postoperative Cognitive DysfunctionNCT05555693
Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
An observational study of POCD - Postoperative Cognitive Dysfunction, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- POCD - Postoperative Cognitive Dysfunction
- What is being tested?
- Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and preoperative cognitive function scales were evaluated.
Who may be able to join
- 65 years or older .
- Complete the operation in our hospital
- ASA classification I-II level
- Agree to participate in this research and agree to sign an informed consent form
Who cannot join
- History of preoperative psychosis and psychotropic drug use
- The subject is diagnosed with AD;
- Abnormal preoperative mental scale assessment
- Have a history of emergency rescue during the perioperative period
- metal implants
- Postoperative immobilization patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai 9Th Hospital
Shanghai, Shanghai Municipality, 200000
Hong Jiang, jianghongjiuyuan@163.com
About this study
Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients.
- Being tested
- Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sampleOther
Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）
| Study group | Role | What they receive |
|---|---|---|
| Patients in the control group were followed up without POCD postoperatively. | If the MOCA or MMSE assessment all show a negative resluts at all time point. Receives: Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample | |
| Patients in the case group were followed up with POCD postoperatively. | If the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time Receives: Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 1 day after surgery
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: immediately before surgery
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 3 day after surgery
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 7 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 1 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 3 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: 7 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
Measured: immediately before surgery
Secondary outcomes (3)
3D-CAM
3D-CAM score
Measured: 1 day after surgery
Self-Rating Anxiety Scale
Self-Rating Anxiety Scale score
Measured: immediately before surgery
Self-rating depression scale
Self-rating depression scale score
Measured: immediately before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start27 Jul 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POCD - Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555693
- Sponsor's protocol ID
- SH9H-2022-T133-2
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
- ClinicalTrials.gov ID
- NCT05555693
- Acronym / sponsor ID
- SH9H-2022-T133-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Sep 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.
Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the control group were followed up without POCD postoperatively. | – | Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sampleIf the MOCA or MMSE assessment all show a negative resluts at all time point. |
| Patients in the case group were followed up with POCD postoperatively. | – | Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sampleIf the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and preoperative cognitive function scales were evaluated.
Key inclusion criteria (4 listed)
- 65 years or older .
- Complete the operation in our hospital
- ASA classification I-II level
- Agree to participate in this research and agree to sign an informed consent form
Key exclusion criteria (6 listed)
- History of preoperative psychosis and psychotropic drug use
- The subject is diagnosed with AD;
- Abnormal preoperative mental scale assessment
- Have a history of emergency rescue during the perioperative period
- metal implants
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 |
|---|---|---|
| Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sampleCollecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and blood sample （before induction of anesthesia and first day, third day and 7th day after surgery） | Other | Patients in the case group were followed up with POCD postoperatively., Patients in the control group were followed up without POCD postoperatively. |
Primary outcome
MMSE (mini-mental state examiniation)
Time frame: 1 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MMSE (mini-mental state examiniation)
Time frame: immediately before surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MMSE (mini-mental state examiniation)
Time frame: 3 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MMSE (mini-mental state examiniation)
Time frame: 7 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MOCA (Montreal Cognitive Assessment)
Time frame: 1 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MOCA (Montreal Cognitive Assessment)
Time frame: 3 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MOCA (Montreal Cognitive Assessment)
Time frame: 7 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
MOCA (Montreal Cognitive Assessment)
Time frame: immediately before surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of POCD.
3 secondary outcomes
3D-CAM
Time frame: 1 day after surgery
Self-Rating Anxiety Scale
Time frame: immediately before surgery
Self-rating depression scale
Time frame: immediately before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- 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.
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 POCD - Postoperative Cognitive Dysfunction, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Sep 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ren Zhou, PhD (15121007303, zhouren77@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (mini-mental state examiniation) (time frame: 1 day after surgery). The study lists 8 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 27 Sep 2022.