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临床试验/NCT04194866
NCT04194866Unknown不适用

The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
postoperative sleep quality of one night before surgery

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Day group

Other

60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group ( 8:00-12:00)

干预措施: receiving operation during the day or at night (Other)

Night group

Other

60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00)

干预措施: receiving operation during the day or at night (Other)

结局指标

主要结局

postoperative sleep quality of one night before surgery

时间窗: 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

时间窗: 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

时间窗: the third night after surgery

use sleep monitor to test the sleep quality third night after surgery

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

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