Clinical trial NCT04611763: Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Official title: Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Flurbiprofen Axetil
Preemptive Analgesia
Postoperative Pain
Perioperative Sleep Quality
Postoperative Inflammatory Markers
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative 24 hours pain score
timeFrame: 24 hours after surgery
measure: perioperative inflammatory markers
timeFrame: the day before surgery
measure: perioperative inflammatory markers
timeFrame: first day after surgery
measure: perioperative inflammatory markers
timeFrame: third day after surgery
Secondary outcomes:
measure: preoperative sleep quality
timeFrame: the first night before surgery
measure: postoperative sleep quality
timeFrame: the first night after surgery
measure: postoperative sleep quality
timeFrame: the third night after surgery
measure: postoperative adverse effects
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: beijing friendship hospital of Capital Medical university
Study officials:
References: