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NCT04611763
Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery.
Phase 1 trial testing Flurbiprofen axetil preoperatively in Flurbiprofen Axetil in 112 participants. Completed in 1 February 2024.
10 October 2023
Quick facts
| Lead sponsor | Beijing Friendship Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 1 September 2021 |
| Primary completion | 10 October 2023 |
| Estimated completion | 1 February 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Flurbiprofen axetil preoperatively — full drug profile →
- Flurbiprofen axetil postoperatively — full drug profile →
Conditions studied
- Flurbiprofen Axetil — all drugs for Flurbiprofen Axetil →
- Preemptive Analgesia — all drugs for Preemptive Analgesia →
- Postoperative Pain — all drugs for Postoperative Pain →
- Perioperative Sleep Quality — all drugs for Perioperative Sleep Quality →
Sponsor
Beijing Friendship Hospital
Who can join
Adults 18 to 75, female only, with Flurbiprofen Axetil or Preemptive Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Preemptive flurbiprofen axetil for sleep-pain-inflammation modulation after laparoscopic gynecological surgery: a prospective, parallel-group randomized controlled trial.
Huang X, Wei W, Leng Z, Song B, et al · · 2025 · PMID 41126955 · DOI 10.3389/fphar.2025.1659179
Verify or expand the search:
- PubMed search for NCT04611763
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04611763 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Friendship Hospital
- Last refreshed: 24 July 2025
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