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

Phase 1

• Conditions: Flurbiprofen Axetil; Preemptive Analgesia; Postoperative Pain; Perioperative Sleep Quality; Postoperative Inflammatory Markers
• Interventions: Drug: Flurbiprofen axetil postoperatively; Drug: Flurbiprofen axetil preoperatively

• Registration Number: NCT04611763
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-02
• Study Start: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post FA Group	Flurbiprofen axetil postoperatively	-
Pre FA Group	Flurbiprofen axetil preoperatively	-

Primary Outcome Measures

Name	Time	Method
Postoperative 24 hours pain score	24 hours after surgery	Use VAS to evaluated postoperative pain score
perioperative inflammatory markers	third day after surgery	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.

Secondary Outcome Measures

Name	Time	Method
preoperative sleep quality	the first night before surgery	evaluate postoperative sleep quality at the first night before surgery
postoperative sleep quality	the third night after surgery	evaluate postoperative sleep quality at the third night after surgery
postoperative adverse effects	24 hours after surgery	evaluate postoperative adverse effects

Trial Locations

Locations (1)

beijing friendship hospital of Capital Medical university; 🇨🇳 Beijing, China