Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality

Study Overview
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Brief Summary
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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.

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

Conditions
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Preemptive Analgesia, Sex Difference, Flurbiprofen Axetil, Postoperative Pain, Postoperative Sleep Quality

Intervention / Treatment
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* Drug: preemptive analgesia with flurbiprofen axetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years; American Society of Anaesthesiologists (ASA) physical status I-Ⅲ. Exclusion Criteria: 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.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male Group<br> | Drug: preemptive analgesia with flurbiprofen axetil<br>* give flurbiprofen axetil 15 min before surgery<br>|
| Active Comparator: Female Group<br> | Drug: preemptive analgesia with flurbiprofen axetil<br>* give flurbiprofen axetil 15 min before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | use Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain | 24 hours after surgery | 
| postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor | use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) | first night before surgery | 
| postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor | use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) | first night after surgery | 
| postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor | use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) | third night after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative adverse effects | evaluate postoperative adverse effects | 24 hours after surgery |