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临床试验/NCT06353516
NCT06353516已完成不适用

Evaluation of the Effect of Intravenous Anesthesia Versus Volatile Anesthesia on Blood-brain Barrier Permeability and Neuroinflammation Affecting Postoperative Cognitive Dysfunction in Elderly Patients: A Randomized Controlled Trial

Chung-Ang University Gwangmyeong Hospital1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年4月10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
已完成
发起方
入组人数
154
试验地点
1
主要终点
Concentration of serum S100B levels

研究概览

简要总结

The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:

  • [Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?]

  • [Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?] Participants will be anesthetized with different categories of anesthetics.

  • Intravenous anesthetics

  • Inhalation gas anesthetics

详细描述

This clinical trial targets patients aged 60 years or older with American Society of Anesthesiologists physical status (ASA) 1 to 3 who undergo surgery under general anesthesia at our hospital. Before entering the operating room, patients are randomly assigned to the intravenous anesthesia group and the inhalation gas anesthesia group. The intravenous anesthesia group uses propofol for anesthesia, and the inhalation gas anesthesia group uses sevoflurane. A 3 mL blood sample is collected four times: before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery. All blood samples will be immediately transferred to the department of Laboratory medicine and stored at -80 degree. Pre-scheduled tests to determine the brain-blood barrier permeability and inflammatory cytokines will be conducted after the recruitment of all samples. In addition, for patients scheduled to be transferred to the intensive care unit (ICU) after surgery among the study subjects, a 3 mL of cerebrospinal fluid sample is collected two times: before surgery, and at the end of surgery. The same preservation protocol will be applied to the cerebrospinal fluid samples. All study subjects will be monitored for postoperative delirium daily for up to 7 days after surgery or until discharge. Cognitive function is assessed using telephone version of the Montreal Cognitive Assessment (T-MOCA) before surgery and 3 months after surgery.

研究设计

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

盲法说明

This study is a double-blinded randomized controlled trial. The group assignment is conducted by the pre-generated random number table. The participant, investigator and the outcome assessor are blinded to the group assignment.

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

  • age equal to or older than 60
  • american Society of Anesthesiologists (ASA) grade I to III
  • general anesthesia longer than 2 hours

排除标准

  • history of dementia
  • history of schizophrenia, epilepsy, or Parkinson's disease
  • history of stroke or craniectomy
  • patient denial

研究组 & 干预措施

Intravenous Anesthesia

Active Comparator

The anesthesia is maintained with intravenous anesthetics

干预措施: Propofol (Drug)

Inhaled Gas Anesthesia

Sham Comparator

The anesthesia is maintained with inhaled gas anesthetics

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Concentration of serum S100B levels

时间窗: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery

Levels of S100B will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.

次要结局

  • Incidence of Delirium(during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days)
  • Concentration of serum TNFα levels(before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery)
  • Incidence of Postoperative Cognitive Dysfunction(before surgery, 3 months after surgery)
  • Concentration of serum CRP(before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery)
  • Concentration of cerebrospinal fluid (CSF) albumin(Within 24 hour before surgery, at the end of surgery)
  • Concentration of serum IL6 levels(before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery)
  • Concentration of serum albumin(before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery)

研究者

发起方
Chung-Ang University Gwangmyeong Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eun Jung Oh

Assistant Professor

Chung-Ang University Gwangmyeong Hospital

研究点 (1)

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