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

NCT ID: NCT04421872

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

Postoperative Delirium; General Anesthesia; Exosomes; Clock Gene; Circadian Rhythm Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

General anesthesia Group

Group Type: EXPERIMENTAL

receiving general anesthesia

Intervention Type: OTHER

patients receiving surgery under general anesthesia

Healthy control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

receiving general anesthesia

patients receiving surgery under general anesthesia

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yanchao Yang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junchao Zhu

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Junchao Zhu

Shenyang, , China

Countries

China

Central Contacts

Junchao Zhu

Role: CONTACT

zhujunchao1@hotmail.com

18940257257

Facility Contacts

Junchao Zhu

Role: primary

zhujunchao1@hotmail.com

18940257257 ext. 18940257257

Other Identifiers

general anesthesia and POCD

Identifier Type: -

Identifier Source: org_study_id