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Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality

The Effect of Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality of Patients Under General Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04627779
Enrollment
100
Registered
2020-11-13
Start date
2021-01-01
Completion date
2021-11-30
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flurbiprofen Axetil, Postoperative Pain, Postoperative Sleep Quality, Preemptive Analgesia, Sex Difference

Brief summary

In humans and animals, circadian rhythm sleep cycle plays an important role on maintaining and regulating 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. This seems to be a common problem 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 vomiting etc after general anesthesia may also reduce postoperative sleep quality.Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids and 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 use flurbiprofen axetil preoperatively is better than use it postoperatively. However, limited information was reported before on the effect of factors such as age, gender, preoperative negative mood such as anxiety and depression, type and length of surgery, which could influence postoperative pain and analgesic consumption and the association between postoperative sleep quality and postoperative pain intensity. At present, there has been less previous evidence for how preemptive analgesic with flurbiprofen axetil affect postoperative sleep quality through its effect on postoperative pain of patients with different sex under general anesthesia.

Interventions

DRUGpreemptive analgesia with flurbiprofen axetil

give flurbiprofen axetil 15 min before surgery

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. age between 18 and 80 years; 2. American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.

Exclusion criteria

1. patients with central nervous system and mental illness; 2. patients with preoperative sleep disorders; 3. patients with a history of sedation, analgesia or antidepressants; 4. patients with sleep apnea or obstructive sleep apnea hypopnea syndrome; 5. patients with chronic gastritis and gastric ulcer 6. patients who are allergic to flurbiprofen axetil.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain24 hours after surgeryuse Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain
postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitorfirst night before surgeryuse sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

Secondary

MeasureTime frameDescription
postoperative adverse effects24 hours after surgeryevaluate postoperative adverse effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026