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临床试验/NCT04421872
NCT04421872Unknown不适用

The Relationship Between the Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Blood samples and Apolipoprotein E genotyping

研究概览

简要总结

Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and over, which refers to cognitive function changes such as memory decline and attention deficit after anesthesia and surgery. In severe cases, personality changes and social behavior decline may also occur, resulting in irreversible cognitive impairment.Previous studies have suggested that cognitive dysfunction after general anesthesia is linked to a genetic disorder of the body clock.Exosomes are cellular forms of cellular microvesicles containing complex RNA and proteins.Exosomes can mediate the expression of genes in the late transcriptional period of the clock system, and directly or indirectly participate in the negative regulation of rhythm expression of minute control genes, playing an important role in the intercellular circadian rhythm information output pathway.Rhythm disorders in the core biological clock system of urinary exosomes and the clock control genes related to kidney can early indicate circadian rhythm changes in the core biological clock system.The sorting and detection of urinary exosome clock information materials in patients has the advantages of easy access, continuous monitoring, early diagnosis and less damage, making urinary exosome a biomarker for the diagnosis and monitoring of circadian rhythm of a good kidney biological clock system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients whose age ≥ 18 years old and <90 years of preoperative sleep disorder;
  • •Primary cancer patients who had not received any radiotherapy or chemotherapy before surgery;
  • •Surgeries expected to be performed under general anesthesia after ≧3 hours

排除标准

  • •a history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
  • •inability to communicate due to coma, severe dementia, language impairment or serious illness;
  • •critically ill (preoperative ASA (American Society of Anesthesiologists)>III), Childe-Pugh C or severe renal insufficiency (preoperative dialysis);
  • •Neurosurgery.

研究组 & 干预措施

General anesthesia Group

Experimental

干预措施: receiving general anesthesia (Other)

Healthy control group

No Intervention

结局指标

主要结局

Blood samples and Apolipoprotein E genotyping

时间窗: at the end of surgery

peripheral blood was collected from each patient for apolipoprotein E genotyping.

Neurocognitive testing

时间窗: 3 years after surgery

Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.

Core clock gene and kidney clock control gene detection

时间窗: at the end of surgery

The urine exosomes were extracted by overspeed centrifugation method. The mRNA ( messenger ribonucleic acid) expression results of the core heart clock gene and the renal bell control genes in the urinary exosomes were detected by timing and quantitative PCR(Polymerase Chain Reaction) and the rhythm was analyzed

Neurocognitive testing

时间窗: one day before the surgery

Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.

Neurocognitive testing

时间窗: 6 weeks after surgery

Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.

Neurocognitive testing

时间窗: 1 year after surgery

Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

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