A Phase 1 interventional study of Flurbiprofen axetil preoperatively and Flurbiprofen axetil postoperatively in Flurbiprofen Axetil, Preemptive Analgesia and Postoperative Pain, sponsored by Beijing Friendship Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Beijing Friendship Hospital · Phase 1, Interventional, and Treatment
In humans and animals, circadian rhythm sleep cycle is an important function to maintain and regulate 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". However, previous studies have shown that 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 vomitting etc after general anesthesia may also reduce postoperative sleep quality.Meanwhile, there is a mixed literature linking sleep and markers of systemic inflammation that greater sleep disturbances were associated with higher levels of circulating IL-6 and CRP but not TNF-α. And the effects of inflammatory cytokines may also cause changes in sleep patterns. Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids. It not only has a high affnity for infammatory tissues to achieve targeted drug therapy and prolonged duration of action, but causes analgesia effect through decreasing the biological production of prostaglandins, reducing the reactivity of peripheral nerves to endogenous infammatory factors, and inhibiting the sensitization of central as well as peripheral nervous systems.Furthermore, it could also inhibite 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 the use of local anesthetics and/or analgesics in advance can prevent central nervous system hyperplasia, thereby reducing postoperative pain. The aim of our study was to investigate the effect of preemptive analgesic with flurbiprofen axetil on postoperative pain, inflammatory markers and sleep quality among patients under general anesthesia. We hypothesized that use flurbiprofen axetil preoperatively would effectively relieve postoperative pain, inhibite inflammtory reaction and improve postoperative sleep quality.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 112 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
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age: 18-75 ASA: I-II Receive operation under general anesthesia
Exclusion Criteria:
①Patients with mental illness;
Severe sleep disorders in the past;
A history of taking opioids;
Patients who are allergic to the drug
Drug: Flurbiprofen axetil preoperatively
Drug: Flurbiprofen axetil postoperatively
give Flurbiprofen axetil 15 min before surgery
give Flurbiprofen axetil at the end of surgery
Postoperative 24 hours pain score
Use VAS to evaluated postoperative pain score
Time frame: 24 hours after surgery
perioperative inflammatory markers
The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.
Time frame: the day before surgery
perioperative inflammatory markers
The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.
Time frame: first day after surgery
perioperative inflammatory markers
The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.
Time frame: third day after surgery
preoperative sleep quality
evaluate postoperative sleep quality at the first night before surgery
Time frame: the first night before surgery
postoperative sleep quality
evaluate postoperative sleep quality at the first night after surgery
Time frame: the first night after surgery
postoperative sleep quality
evaluate postoperative sleep quality at the third night after surgery
Time frame: the third night after surgery
postoperative adverse effects
evaluate postoperative adverse effects
Time frame: 24 hours after surgery
Plan to share: No
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Beijing Friendship Hospital