Clinical trial NCT04627779: Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality
Official title: The Effect of Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality of Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preemptive Analgesia
Sex Difference
Flurbiprofen Axetil
Postoperative Pain
Postoperative Sleep Quality
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours after surgery
measure: postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
timeFrame: first night before surgery
measure: postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
timeFrame: first night after surgery
measure: postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
timeFrame: third night after surgery
Secondary outcomes:
measure: postoperative adverse effects
timeFrame: 24 hours after surgery
Other outcomes:
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