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

Sponsor

Shengjing Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04421872

Collaborator

(none)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

23.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium General Anesthesia Exosomes Clock Gene Circadian Rhythm Disorders	Other: receiving general anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: General anesthesia Group	Other: receiving general anesthesia patients receiving surgery under general anesthesia
No Intervention: Healthy control group

Arm

Intervention/Treatment

Experimental: General anesthesia Group

Other: receiving general anesthesia

patients receiving surgery under general anesthesia

No Intervention: Healthy control group

Outcome Measures

Primary Outcome Measures

Neurocognitive testing [one day before the surgery]
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing [6 weeks after surgery]
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing [1 year after surgery]
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing [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 [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
Blood samples and Apolipoprotein E genotyping [at the end of surgery]
peripheral blood was collected from each patient for apolipoprotein E genotyping.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.