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

NCT ID: NCT04627779

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-11-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Male Group

Group Type: EXPERIMENTAL

preemptive analgesia with flurbiprofen axetil

Intervention Type: DRUG

give flurbiprofen axetil 15 min before surgery

Female Group

Group Type: ACTIVE_COMPARATOR

preemptive analgesia with flurbiprofen axetil

Intervention Type: DRUG

give flurbiprofen axetil 15 min before surgery

Interventions

preemptive analgesia with flurbiprofen axetil

give flurbiprofen axetil 15 min before surgery

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bijia Song

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Sex difference and pain

Identifier Type: -

Identifier Source: org_study_id