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Completed

NCT Number: NCT04611763

Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery.

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

beijing friendship hospital of Capital Medical university

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flurbiprofen axetil preoperatively

Drug

give Flurbiprofen axetil 15 min before surgery

Flurbiprofen axetil postoperatively

Drug

give Flurbiprofen axetil at the end of surgery

Primary outcomes

  1. Postoperative 24 hours pain score

    Time frame: 24 hours after surgery

    Use VAS to evaluated postoperative pain score

  2. perioperative inflammatory markers

    Time frame: the day before surgery

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

  3. perioperative inflammatory markers

    Time frame: first day after surgery

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

  4. perioperative inflammatory markers

    Time frame: third day after surgery

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

Secondary outcomes

  1. preoperative sleep quality

    Time frame: the first night before surgery

    evaluate postoperative sleep quality at the first night before surgery

  2. postoperative sleep quality

    Time frame: the first night after surgery

    evaluate postoperative sleep quality at the first night after surgery

  3. postoperative sleep quality

    Time frame: the third night after surgery

    evaluate postoperative sleep quality at the third night after surgery

  4. postoperative adverse effects

    Time frame: 24 hours after surgery

    evaluate postoperative adverse effects

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 2, 2020
Registry last updated
Jul 24, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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