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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04421872
• Other study ID #: general anesthesia and POCD
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Shengjing Hospital
• Contact: Junchao Zhu
• Phone: 18940257257
• Email: zhujunchao1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Clock Gene
• Cognitive Dysfunction
• Delirium
• Disease
• Exosomes
• General Anesthesia
• Postoperative Delirium

Intervention

Other:
• receiving general anesthesia
patients receiving surgery under general anesthesia

Locations

Country	Name	City	State
China	Junchao Zhu	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive testing	Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.	one day before the surgery
Primary	Neurocognitive testing	Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.	6 weeks after surgery
Primary	Neurocognitive testing	Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.	1 year after surgery
Primary	Neurocognitive testing	Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.	3 years after surgery
Primary	Core clock gene and kidney clock control gene detection	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	at the end of surgery
Primary	Blood samples and Apolipoprotein E genotyping	peripheral blood was collected from each patient for apolipoprotein E genotyping.	at the end of surgery