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临床试验/NCT04627779
NCT04627779Unknown不适用

The Effect of Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality of Patients Under General Anesthesia

Beijing Friendship Hospital0 个研究点目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
主要终点
postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor

研究概览

简要总结

In humans and animals, circadian rhythm sleep cycle plays an important role on maintaining and regulating basic physiological homeostasis, such as cognitive function, glucose metabolism, memory consolidation, immune function and growth hormone secretion. The induction of general anesthesia leads to a state of reduced responsiveness, which is often described by anesthesiologists and patients as "sleep". This seems to be a common problem in the case of patients under general anesthesia, besides surgery trauma and general anesthetics may change sleep function and sleep cycle perioperatively, the postoperative complications such as pain, nausea and vomiting etc after general anesthesia may also reduce postoperative sleep quality.Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids and the occurrence of adverse reactions, such as declined sleep quality, respiratory depression, nausea and vomiting . Preemptive analgesia is an analgesic intervention that begins before surgery to prevent the nervous system from becoming sensitive to subsequent stimuli that may aggravate pain. A large number of experimental studies have shown that use flurbiprofen axetil preoperatively is better than use it postoperatively. However, limited information was reported before on the effect of factors such as age, gender, preoperative negative mood such as anxiety and depression, type and length of surgery, which could influence postoperative pain and analgesic consumption and the association between postoperative sleep quality and postoperative pain intensity. At present, there has been less previous evidence for how preemptive analgesic with flurbiprofen axetil affect postoperative sleep quality through its effect on postoperative pain of patients with different sex under general anesthesia.

研究设计

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

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

  • age between 18 and 80 years;
  • American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.

排除标准

  • patients with central nervous system and mental illness;
  • patients with preoperative sleep disorders;
  • patients with a history of sedation, analgesia or antidepressants;
  • patients with sleep apnea or obstructive sleep apnea hypopnea syndrome;
  • patients with chronic gastritis and gastric ulcer
  • patients who are allergic to flurbiprofen axetil.

研究组 & 干预措施

Female Group

Active Comparator

干预措施: preemptive analgesia with flurbiprofen axetil (Drug)

Male Group

Experimental

干预措施: preemptive analgesia with flurbiprofen axetil (Drug)

结局指标

主要结局

postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor

时间窗: third night after surgery

use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

postoperative pain

时间窗: 24 hours after surgery

use Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain

次要结局

  • 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

Bijia Song

principal investigator

Beijing Friendship Hospital

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