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临床试验/NCT06005363
NCT06005363招募中不适用

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.

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
NMR amd LC-MS CSF and plasma metabolomics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

DEX group

Experimental

use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion.

干预措施: Dexmedetomidine (Drug)

BIS group

Experimental

Use BIS monitoring to adjust intraoperative anesthetics.

干预措施: anesthesia depth monitoring (Device)

DEX group

Experimental

use BIS monitoring to adjust anesthetics and give dexmedetomidine infusion.

干预措施: anesthesia depth monitoring (Device)

结局指标

主要结局

NMR amd LC-MS CSF and plasma metabolomics

时间窗: preoperative, postoperative 2 hours, postoperative day 1

NMR and LC-MS metabolomics of CSF and plasma samples

Postoperative cognitive function

时间窗: postoperative 2 hours, postoperative day 1, postoperative day 2, postoperative day 3

MMSE, MoCA, CAM-ICU score

次要结局

  • Glymphatic function(preoperative, postoperative day 1)
  • Neuroinflammation parameters(preoperative, postoperative 2 hours, postoperative day 1)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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