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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611763
• Other study ID #: Flurbiprofen axetil
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2021
• Source: Beijing Friendship Hospital
• Contact: Bijia Song
• Phone: +8618309845273
• Email: 630992254[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

age: 18-75 ASA: I-II Receive operation under general anesthesia

Exclusion Criteria:

• ?Patients 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.

Related Conditions & MeSH terms

• Flurbiprofen Axetil
• Pain, Postoperative
• Postoperative Pain
• Preemptive Analgesia

Intervention

Drug:
• Flurbiprofen axetil preoperatively
give Flurbiprofen axetil 15 min before surgery
• Flurbiprofen axetil postoperatively
give Flurbiprofen axetil at the end of surgery

Locations

Country	Name	City	State
China	beijing friendship hospital of Capital Medical university	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative 24 hours pain score	Use VAS to evaluated postoperative pain score	24 hours after surgery
Primary	perioperative inflammatory markers	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.	the day before surgery
Primary	perioperative inflammatory markers	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.	first day after surgery
Primary	perioperative inflammatory markers	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.	third day after surgery
Secondary	preoperative sleep quality	evaluate postoperative sleep quality at the first night before surgery	the first night before surgery
Secondary	postoperative sleep quality	evaluate postoperative sleep quality at the first night after surgery	the first night after surgery
Secondary	postoperative sleep quality	evaluate postoperative sleep quality at the third night after surgery	the third night after surgery
Secondary	postoperative adverse effects	evaluate postoperative adverse effects	24 hours after surgery