Clinical trial NCT04194866: The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
Official title: The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circadian Clock
Postoperative Cognitive Function
General Anesthesia
Elderly Patients
Keywords: circadian clock
postoperative cognitive function
general anesthesia
elderly patients
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

* preoperative sleep disorders
* did not receive any preoperative chemoradiotherapy
* the duration of surgery ≧3 hours

Exclusion Criteria:

* History of schizophrenia
* epilepsy
* 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

Primary outcomes:
measure: postoperative sleep quality of one night before surgery
timeFrame: one night before the surgery
measure: postoperative sleep quality of first night after surgery
timeFrame: the first night after surgery
measure: postoperative sleep quality of third night after surgery
timeFrame: the third night after surgery
Secondary outcomes:
measure: Preoperative cognitive function test
timeFrame: one day before surgery
measure: Postoperative cognitive function test of 6 weeks after surgery
timeFrame: 6 weeks after surgery
measure: Postoperative cognitive function test of 1 year after surgery
timeFrame: 1 year after surgery
measure: Postoperative cognitive function test of 3 years after surgery
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Junchao hospital Zhu
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Junchao Zhu
role: STUDY_DIRECTOR
References: