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CSF Metabolomics and Glymphatic Function in Patients Receiving VP- Shunt Surgery.

Primary Purpose

The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation, The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic Change

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dexmedetomidine
anesthesia depth monitoring
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for The Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation focused on measuring anesthesia depth monitoring, postoperative cognitive dysfunction, metabolomics, cerebrospinal fluid, glymphatic function

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Linkou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

BIS group

DEX group

Usual group

Arm Description

Use BIS monitoring to adjust intraoperative anesthetics.

use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion.

usual care with 1 MAC sevoflurane maintainance.

Outcomes

Primary Outcome Measures

Postoperative cognitive function
MMSE, MoCA, CAM-ICU score
NMR amd LC-MS CSF and plasma metabolomics
NMR and LC-MS metabolomics of CSF and plasma samples

Secondary Outcome Measures

Neuroinflammation parameters
lactate, tau protein, amyloid beta, orexin, IL-6, IL-10, TNF-alpha, s100b
Glymphatic function
evaluate DTI-ALPS index in 3T functional MRI

Full Information

First Posted
August 7, 2023
Last Updated
August 17, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06005363
Brief Title
CSF Metabolomics and Glymphatic Function in Patients Receiving VP- Shunt Surgery.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two interventional group with BIS group and DEX group all receive BIS monitoring, and DEX group receive dexmedetomidine infusion.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants receive randomized allocation to BIS, DEX, or usual care group before VP shunt surgery. Outcome assessor evaluate the preoperative and postoperative cognitive function, delirium status, and evaluate glymphatic function with functional MRI.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BIS group
Arm Type
Experimental
Arm Description
Use BIS monitoring to adjust intraoperative anesthetics.
Arm Title
DEX group
Arm Type
Experimental
Arm Description
use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion.
Arm Title
Usual group
Arm Type
No Intervention
Arm Description
usual care with 1 MAC sevoflurane maintainance.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEX
Intervention Description
dexmedetomidine infusion
Intervention Type
Device
Intervention Name(s)
anesthesia depth monitoring
Other Intervention Name(s)
BIS
Intervention Description
intraoperative anesthesia depth monitoring to keep BIS 40-60
Primary Outcome Measure Information:
Title
Postoperative cognitive function
Description
MMSE, MoCA, CAM-ICU score
Time Frame
postoperative 2 hours, postoperative day 1, postoperative day 2, postoperative day 3
Title
NMR amd LC-MS CSF and plasma metabolomics
Description
NMR and LC-MS metabolomics of CSF and plasma samples
Time Frame
preoperative, postoperative 2 hours, postoperative day 1
Secondary Outcome Measure Information:
Title
Neuroinflammation parameters
Description
lactate, tau protein, amyloid beta, orexin, IL-6, IL-10, TNF-alpha, s100b
Time Frame
preoperative, postoperative 2 hours, postoperative day 1
Title
Glymphatic function
Description
evaluate DTI-ALPS index in 3T functional MRI
Time Frame
preoperative, postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan-Tang Lin, MD
Phone
+886-33281200
Ext
2324
Email
sanctuary12@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan-tang Lin
Organizational Affiliation
Department of anesthesiology, Linkou Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan-tang Lin
Phone
033281200
Ext
2324
Email
sanctuary12@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
personal data is encrypted

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CSF Metabolomics and Glymphatic Function in Patients Receiving VP- Shunt Surgery.

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