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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04421872
Other study ID # general anesthesia and POCD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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