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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; General Anesthesia; Circadian Rhythm Disorders; Exosomes; Clock Gene
• Intervention / Treatment: Other: receiving general anesthesia

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junchao Zhu; Phone Number: 18940257257; Email: zhujunchao1@hotmail.com

Study Locations

• China
  • Shenyang, China, 110004
    • Junchao Zhu
    • Contact: Junchao Zhu; Phone Number: 18940257257 18940257257; Email: zhujunchao1@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Healthy control group
EXPERIMENTAL: General anesthesia Group	Other: receiving general anesthesia; patients receiving surgery under general anesthesia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: junchao zhu, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; Circadian Rhythm Disorders; Exosomes; Postoperative Delirium; clock gene
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Disease; Cognitive Dysfunction; Chronobiology Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: general anesthesia and POCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No