The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and NeuroinflammationNCT06005363
CSF Metabolomics and Glymphatic Function in Patients Receiving VP- Shunt Surgery.
A study testing Dexmedetomidine and anesthesia depth monitoring in people with The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation and The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
In this randomized control study, the investigators intended to evaluate the influence of different anesthetics on postoperative cognitive dysfunction, neuroinflammation, CSF metabolomics, and glymphatic function in patients with normal pressure hydrocephalus for VP shunt surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation, The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change
- What is being tested?
- Dexmedetomidine and anesthesia depth monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 30 Jun 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with communicating hydrocephalus for elective VP shunt surgery under general anesthesia
- age> 60 y/o
- conscious clear
- fluency in Chinese
- anticipated hospital stay ≥ 3 days after surgery
Who cannot join
- unstable preoperative condition (unstable angina, CHF, asthma attack) within 4 weeks before surgery,
- severe hepatic dysfunction or renal failure
- history of neuropsychological diseases such as schizophrenia, Parkinson's disease, dementia, stroke,
- pre-op cognitive impairment,
- preoperative delirium,
- preoperative depression,
- allergy to contrast medium of MRI.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Huan-tang Lin, 033281200 ext. 2324, sanctuary12@cgmh.org.tw
About this study
Official title: The Application of Anesthesia Depth Monitoring on Post-operative Cognitive Dysfunction for Patients With Hydrocephalus Receiving Ventricular-peritoneal Shunt Surgery and Associated Change in CSF Metabolomics and Glymphatic Function.
In this randomized control study, the investigators intended to evaluate the influence of different anesthetics on postoperative cognitive dysfunction, neuroinflammation, CSF metabolomics, and glymphatic function in patients with normal pressure hydrocephalus for VP shunt surgery. The investigators assume that the use of dexmedetomidine infusion and proper anesthsia depth during general anesthesia, in addition to multi-model analgesia, might be helpful to enhance glymphatic function, reduce neuroinflammation, and decrease postoperative cognitive dysfunction.
Read the detailed description
In this prospective randomized controlled study, 48 patients with communicating hydrocephalus will be enrolled in the study and these patients will be divided into 3 groups in which intervention group received anesthesia depth monitoring (BIS group and DEX group) and dexmedetomidine infusion (DEX group), while the controlled group received usual anesthesia care without dexmedetomidine during VP shunt surgery. The participant's intraoperative CSF and plasma samples will be collected for biochemical analysis and metabolomic analysis. The investigators will use two analytical metabolomic platforms, including nuclear magnetic resonance (NMR) and liquid chromatography-mass spectrometry (LC-MS), to execute quantitative metabolomics on human CSF and plasma samples. These metabolomic data will be compared with previous established human aging CSF Metabolome Database. After VP shunt surgery, these patient's glymphatic function will be evaluated with 3T functional MRI. The postoperative cognitive function and delirium status of these patients will be evaluated for the following 3 days using MMSE score, Montreal Cognitive Assessment, and CAM-ICU score. During analysis, the pre-operative metabolomic signature of patients with postoperative cognitive dysfunction(POCD) will be compared with patients without POCD to profile the metabolomics of POCD. Besides, the investigators could examine the correlation of glymphatic function and POCD. By comparing the CSF metabolomic change in these three groups, the investigators could evaluate the the efficacy of anesthesia depth monitoring and dexmedetomidine to reduce POCD development during VP shunt surgery. The result of this study might be able to explain the brain pathophysiology of POCD, the role of glymphatic function in POCD, metabolomic signature of POCD, and establish a better anesthesia regimen to reduce the development of POCD.
- Conditions
- The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation, The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change
- Being tested
- Dexmedetomidine, anesthesia depth monitoring
- Keywords
- anesthesia depth monitoring, postoperative cognitive dysfunction, metabolomics, cerebrospinal fluid, glymphatic function
- Medical subject headings
- Neuroinflammatory Diseases, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
dexmedetomidine infusion
anesthesia depth monitoringDevice
Also called BIS
intraoperative anesthesia depth monitoring to keep BIS 40-60
| Study group | Role | What they receive |
|---|---|---|
| BIS group | Experimental | Use BIS monitoring to adjust intraoperative anesthetics. Receives: Device: anesthesia depth monitoring |
| DEX group | Experimental | use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion. Receives: Drug: Dexmedetomidine; Device: anesthesia depth monitoring |
| Usual group | No intervention | usual care with 1 MAC sevoflurane maintainance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive function
MMSE, MoCA, CAM-ICU score
Measured: postoperative 2 hours, postoperative day 1, postoperative day 2, postoperative day 3
NMR amd LC-MS CSF and plasma metabolomics
NMR and LC-MS metabolomics of CSF and plasma samples
Measured: preoperative, postoperative 2 hours, postoperative day 1
Secondary outcomes (2)
Neuroinflammation parameters
lactate, tau protein, amyloid beta, orexin, IL-6, IL-10, TNF-alpha, s100b
Measured: preoperative, postoperative 2 hours, postoperative day 1
Glymphatic function
evaluate DTI-ALPS index in 3T functional MRI
Measured: preoperative, postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and NeuroinflammationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two interventional group with BIS group and DEX group all receive BIS monitoring, and DEX group receive dexmedetomidine infusion.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huan-tang Lin, Principal investigator, Department of anesthesiology, Linkou Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005363
- Sponsor's protocol ID
- CMRPG3N0591
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: personal data is encrypted
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Anesthesia Depth Monitoring on Post-operative Cognitive Dysfunction for Patients With Hydrocephalus Receiving Ventricular-peritoneal Shunt Surgery and Associated Change in CSF Metabolomics and Glymphatic Function.
- ClinicalTrials.gov ID
- NCT06005363
- Acronym / sponsor ID
- CMRPG3N0591
- Conditions
- The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation, The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change
- Keywords
- anesthesia depth monitoring, postoperative cognitive dysfunction, metabolomics, cerebrospinal fluid, glymphatic function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Aug 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.
In this randomized control study, the investigators intended to evaluate the influence of different anesthetics on postoperative cognitive dysfunction, neuroinflammation, CSF metabolomics, and glymphatic function in patients with normal pressure hydrocephalus for VP shunt surgery. The investigators assume that the use of dexmedetomidine infusion and proper anesthsia depth during general anesthesia, in addition to multi-model analgesia, might be helpful to enhance glymphatic function, reduce neuroinflammation, and decrease postoperative cognitive dysfunction.
Detailed description
In this prospective randomized controlled study, 48 patients with communicating hydrocephalus will be enrolled in the study and these patients will be divided into 3 groups in which intervention group received anesthesia depth monitoring (BIS group and DEX group) and dexmedetomidine infusion (DEX group), while the controlled group received usual anesthesia care without dexmedetomidine during VP shunt surgery. The participant's intraoperative CSF and plasma samples will be collected for biochemical analysis and metabolomic analysis. The investigators will use two analytical metabolomic platforms, including nuclear magnetic resonance (NMR) and liquid chromatography-mass spectrometry (LC-MS), to execute quantitative metabolomics on human CSF and plasma samples. These metabolomic data will be compared with previous established human aging CSF Metabolome Database. After VP shunt surgery, these patient's glymphatic function will be evaluated with 3T functional MRI. The postoperative cognitive function and delirium status of these patients will be evaluated for the following 3 days using MMSE score, Montreal Cognitive Assessment, and CAM-ICU score. During analysis, the pre-operative metabolomic signature of patients with postoperative cognitive dysfunction(POCD) will be compared with patients without POCD to profile the metabolomics of POCD. Besides, the investigators could examine the correlation of glymphatic function and POCD. By comparing the CSF metabolomic change in these three groups, the investigators could evaluate the the efficacy of anesthesia depth monitoring and dexmedetomidine to reduce POCD development during VP shunt surgery. The result of this study might be able to explain the brain pathophysiology of POCD, the role of glymphatic function in POCD, metabolomic signature of POCD, and establish a better anesthesia regimen to reduce the development of POCD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Two interventional group with BIS group and DEX group all receive BIS monitoring, and DEX group receive dexmedetomidine infusion.
| Arm | Type | Receives |
|---|---|---|
| BIS group | Experimental | Device: anesthesia depth monitoringUse BIS monitoring to adjust intraoperative anesthetics. |
| DEX group | Experimental | Drug: Dexmedetomidine, Device: anesthesia depth monitoringuse BIS monitoring to adjust anesthetics and give dexmedetomidine infusion. |
| Usual group | No intervention | –usual care with 1 MAC sevoflurane maintainance. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with communicating hydrocephalus for elective VP shunt surgery under general anesthesia
- age> 60 y/o
- conscious clear
- fluency in Chinese
- anticipated hospital stay ≥ 3 days after surgery
Key exclusion criteria (7 listed)
- unstable preoperative condition (unstable angina, CHF, asthma attack) within 4 weeks before surgery,
- severe hepatic dysfunction or renal failure
- history of neuropsychological diseases such as schizophrenia, Parkinson's disease, dementia, stroke,
- pre-op cognitive impairment,
- preoperative delirium,
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 |
|---|---|---|
| DexmedetomidineAlso: DEXdexmedetomidine infusion | Drug | DEX group |
| anesthesia depth monitoringAlso: BISintraoperative anesthesia depth monitoring to keep BIS 40-60 | Device | BIS group, DEX group |
Primary outcome
Postoperative cognitive function
Time frame: postoperative 2 hours, postoperative day 1, postoperative day 2, postoperative day 3
MMSE, MoCA, CAM-ICU score
NMR amd LC-MS CSF and plasma metabolomics
Time frame: preoperative, postoperative 2 hours, postoperative day 1
NMR and LC-MS metabolomics of CSF and plasma samples
2 secondary outcomes
Neuroinflammation parameters
Time frame: preoperative, postoperative 2 hours, postoperative day 1
Glymphatic function
Time frame: preoperative, postoperative day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No. personal data is encrypted
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.
Huan-tang Lin principal investigator
Department of anesthesiology, Linkou Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and anesthesia depth monitoring in people with The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation and The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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 22 Aug 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 Taiwan. 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 Huan-Tang Lin, MD (+886-33281200 ext. 2324, sanctuary12@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive function (time frame: postoperative 2 hours, postoperative day 1, postoperative day 2, postoperative day 3). The study lists 2 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 22 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.