Clinical trial NCT04421872: The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
Official title: The Relationship Between the Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Delirium
General Anesthesia
Exosomes
Clock Gene
Circadian Rhythm Disorders
Keywords: Postoperative Delirium
general anesthesia
Exosomes
clock gene
Circadian Rhythm Disorders
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neurocognitive testing
timeFrame: one day before the surgery
measure: Neurocognitive testing
timeFrame: 6 weeks after surgery
measure: Neurocognitive testing
timeFrame: 1 year after surgery
measure: Neurocognitive testing
timeFrame: 3 years after surgery
measure: Core clock gene and kidney clock control gene detection
timeFrame: at the end of surgery
measure: Blood samples and Apolipoprotein E genotyping
timeFrame: at the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Junchao Zhu
Study officials:
affiliation: Shengjing Hospital
name: Junchao Zhu
role: PRINCIPAL_INVESTIGATOR
References: