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临床试验/NCT05059548
NCT05059548Unknown不适用

Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
preoperative inflammation function

研究概览

简要总结

Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years old
  • ASA I-III
  • under general anesthesia

排除标准

  • patients with central nervous system and mental diseases;
  • patients with preoperative sleep disturbances;
  • patients with a history of sedative, analgesic, or antidepression drug use;
  • patients with sleep apnea or moderate and severe obstructive sleep apneahypopnea syndrome;

结局指标

主要结局

preoperative inflammation function

时间窗: three days before surgery

evaluate monocyte / lymphocyte ratio (MLR) before operation

neuropsychological test

时间窗: Neuropsychological tests were carried out the day before and 5 to 7 days after surgery. The second neuropsychological test time for control subjects was 6 to 9 d

The neuropsychological test battery included the tests used to evaluate patients for delayed neurocognitive recovery in the International Study of Post-Operative Cognitive Dysfunction: (1) word learning: visual verbal learning test based on the Rey's auditory recall of words; (2) word recall: the number or words recalled from visual verbal learning trials after a 20-min delay; (3) cognitive flexibility: including trail making test A and B; (4) distractibility: Stroop color word interference test; and (5) working memory: letter-digit coding. If a patient exhibited delirium at a testing time, neuropsychological evaluation was postponed 3 days.

sleep quality of third night after surgery

时间窗: third night after surgery

use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

sleep quality of first night after surgery

时间窗: first night after surgery

use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

sleep quality of one night before surgery

时间窗: one night before surgery

use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

postoperative inflammation function

时间窗: three days after surgery

evaluate monocyte / lymphocyte ratio (MLR) after operation

次要结局

  • visual analog scale(VAS) score after surgery(24 hours after surgery)
  • postoperative adverse effects(24 hours 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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