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

NCT06005363 | Recruiting DMC

• 1 other identifier: CMRPG3N0591
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Postoperative cognitive function

  MMSE, MoCA, CAM-ICU score

  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

  preoperative, postoperative 2 hours, postoperative day 1

Secondary Outcomes (2)

• Neuroinflammation parameters

  preoperative, postoperative 2 hours, postoperative day 1

• Glymphatic function

  preoperative, postoperative day 1

Study Arms (3)

BIS group

EXPERIMENTAL

Use BIS monitoring to adjust intraoperative anesthetics.

Device: anesthesia depth monitoring

DEX group

EXPERIMENTAL

use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion.

Drug: Dexmedetomidine; Device: anesthesia depth monitoring

Usual group

NO INTERVENTION

usual care with 1 MAC sevoflurane maintainance.

Interventions

Dexmedetomidine DRUG

dexmedetomidine infusion

Also known as: DEX

DEX group

anesthesia depth monitoring DEVICE

intraoperative anesthesia depth monitoring to keep BIS 40-60

Also known as: BIS

BIS group; DEX group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Neuroinflammatory Diseases; Postoperative Cognitive Complications

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huan-tang Lin

  Department of anesthesiology, Linkou Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan-Tang Lin, MD

CONTACT

+886-33281200; sanctuary12@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventional group with BIS group and DEX group all receive BIS monitoring, and DEX group receive dexmedetomidine infusion.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)