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

NCT04421872 | Unknown

• 1 other identifier: general anesthesia and POCD
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Postoperative Delirium; general anesthesia; Exosomes; clock gene; Circadian Rhythm Disorders

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

General anesthesia Group

EXPERIMENTAL

Other: receiving general anesthesia

Healthy control group

NO INTERVENTION

Interventions

receiving general anesthesia OTHER

patients receiving surgery under general anesthesia

General anesthesia Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Junchao Zhu

Shenyang, 110004, China

Location

MeSH Terms

Conditions

Emergence Delirium; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Junchao Zhu

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junchao Zhu

CONTACT

18940257257; zhujunchao1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)