The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Shengjing Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- postoperative sleep quality of one night before surgery
Study Overview
Brief Summary
Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and above. It refers to the cognitive function changes such as memory decline and attention loss after anesthesia and surgery. In serious cases, people may also experience personality changes and decline in social behavior ability, which will develop into irreversible cognitive impairment.Some studies reported that 25.8% of elderly patients presented POCD one week after non-cardiac surgery, and the incidence at 3 months after surgery was still 9.9%, which could increase the mortality in the first year after surgery.In recent years, studies have also proved that POCD is associated with patients' inability to perform their original jobs after non-cardiac surgery.Postoperative cognitive dysfunction seriously affects the clinical outcome, in addition to medical costs and other issues will bring an impact on the society and family.With the aging of the population, how to prevent cognitive dysfunction in elderly patients is a major challenge for perioperative management.There is a certain correlation between circadian rhythm and the dosage of general anesthesia, and postoperative sleep disturbance may be related to the effect of anesthesia and surgery on circadian rhythm.Preoperative sleep deprivation is known to be an independent risk factor for postoperative cognitive dysfunction (POCD), but the circadian mechanisms involved after general anesthesia are not yet clear
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •preoperative sleep disorders
- •did not receive any preoperative chemoradiotherapy
- •the duration of surgery ≧3 hours
Exclusion Criteria
- •History of schizophrenia
- •parkinson's disease or myasthenia gravis
- •Critical illness (preoperative American society of anesthesiologists (ASA) ASA >III)
- •severe liver insufficiency (ChildePugh grade C)
- •severe renal insufficiency (preoperative dialysis)
- •neurosurgery
Outcomes
Primary Outcomes
postoperative sleep quality of one night before surgery
Time Frame: one night before the surgery
use sleep monitor to test the sleep quality one night before surgery
postoperative sleep quality of first night after surgery
Time Frame: the first night after surgery
use sleep monitor to test the sleep quality first night after surgery
postoperative sleep quality of third night after surgery
Time Frame: the third night after surgery
use sleep monitor to test the sleep quality third night after surgery
Secondary Outcomes
- Preoperative cognitive function test(one day before surgery)
- Postoperative cognitive function test of 6 weeks after surgery(6 weeks after surgery)
- Postoperative cognitive function test of 1 year after surgery(1 year after surgery)
- Postoperative cognitive function test of 3 years after surgery(3 years after surgery)
Investigators
Yanchao Yang
Principal investigator
Shengjing Hospital