The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
Primary Purpose
Postoperative Delirium, General Anesthesia, Exosomes
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
receiving general anesthesia
Sponsored by
About this trial
This is an interventional other trial for Postoperative Delirium focused on measuring Postoperative Delirium, general anesthesia, Exosomes, clock gene, Circadian Rhythm Disorders
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.
Sites / Locations
- Junchao Zhu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
General anesthesia Group
Healthy control group
Arm Description
Outcomes
Primary Outcome Measures
Neurocognitive testing
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Neurocognitive testing
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
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
peripheral blood was collected from each patient for apolipoprotein E genotyping.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04421872
Brief Title
The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
Official Title
The Relationship Between the Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, General Anesthesia, Exosomes, Clock Gene, Circadian Rhythm Disorders
Keywords
Postoperative Delirium, general anesthesia, Exosomes, clock gene, Circadian Rhythm Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia Group
Arm Type
Experimental
Arm Title
Healthy control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
receiving general anesthesia
Intervention Description
patients receiving surgery under general anesthesia
Primary Outcome Measure Information:
Title
Neurocognitive testing
Description
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Time Frame
one day before the surgery
Title
Neurocognitive testing
Description
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Time Frame
6 weeks after surgery
Title
Neurocognitive testing
Description
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Time Frame
1 year after surgery
Title
Neurocognitive testing
Description
Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
Time Frame
3 years after surgery
Title
Core clock gene and kidney clock control gene detection
Description
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
Time Frame
at the end of surgery
Title
Blood samples and Apolipoprotein E genotyping
Description
peripheral blood was collected from each patient for apolipoprotein E genotyping.
Time Frame
at the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junchao Zhu
Phone
18940257257
Email
zhujunchao1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Junchao Zhu
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu
Phone
18940257257
Ext
18940257257
Email
zhujunchao1@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia
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