Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.

Conditions
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Postoperative Inflammatory Markers, Flurbiprofen Axetil, Preemptive Analgesia, Postoperative Pain, Perioperative Sleep Quality

Intervention / Treatment
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* Drug: Flurbiprofen axetil preoperatively
* Drug: Flurbiprofen axetil postoperatively


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patients who have difficulty communicating and refuse to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre FA Group<br> | Drug: Flurbiprofen axetil preoperatively<br>* give Flurbiprofen axetil 15 min before surgery<br>|
| Active Comparator: Post FA Group<br> | Drug: Flurbiprofen axetil postoperatively<br>* give Flurbiprofen axetil at the end of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 24 hours pain score | Use VAS to evaluated postoperative pain score | 24 hours after surgery | 
| perioperative inflammatory markers | The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count. | the day before surgery | 
| perioperative inflammatory markers | The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count. | first day after surgery | 
| perioperative inflammatory markers | The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count. | third day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative sleep quality | evaluate postoperative sleep quality at the first night before surgery | the first night before surgery | 
| postoperative sleep quality | evaluate postoperative sleep quality at the first night after surgery | the first night after surgery | 
| postoperative sleep quality | evaluate postoperative sleep quality at the third night after surgery | the third night after surgery | 
| postoperative adverse effects | evaluate postoperative adverse effects | 24 hours after surgery |