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临床试验/NCT06466083
NCT06466083招募中不适用

Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Spinal Surgery Patients

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2025年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
165
试验地点
1
主要终点
change in serum indexes between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery

研究概览

简要总结

This study is a prospective cohort study to investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

详细描述

To investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Neurocognitive function of the study participants was assessed within one week before surgery using the Montreal Cognitive Assessment (MoCA). Compare changes in serum indexes level before and after surgery. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. Neurocognitive function assessments were conducted long-term after surgery for the POD group to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups, followed by serum indexes.By comparing the changes of serum indexes before and after surgery between the pNCD and non-pNCD subgroups, exploring the correlation of POD and pNCD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥65 years of age who have undergone spinal surgery anesthesia; Sign informed consent

排除标准

  • Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases

结局指标

主要结局

change in serum indexes between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery

时间窗: 2024.5.9-2026.5.1

Perioperative neurocognitive disorders (PND) represent one of the common complications of general anesthesia, posing serious hazards and currently being a hot topic and a challenging problem in international research. Recently, general anesthesia has led to a new breakthrough in the study of PND serum-related markers, such as brain-derived nutritional factors(BDNF)、C-reactive protein(CRP)、homocysteine(Hcy). This provides new perspectives for PND prevention, evaluation and furnishes theoretical grounds for enhancing the safety of clinical anesthesia and the quality of life for patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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