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

• ClinicalTrials.gov Identifier: NCT04627779
• Recruitment Status: Not yet recruiting
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Sponsor: Beijing Friendship Hospital
• Information provided by (Responsible Party): Bijia Song, Beijing Friendship Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preemptive Analgesia; Sex Difference; Flurbiprofen Axetil; Postoperative Pain; Postoperative Sleep Quality	Drug: preemptive analgesia with flurbiprofen axetil	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality of Patients Under General Anesthesia
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: November 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Male Group	Drug: preemptive analgesia with flurbiprofen axetil; give flurbiprofen axetil 15 min before surgery
Active Comparator: Female Group	Drug: preemptive analgesia with flurbiprofen axetil; give flurbiprofen axetil 15 min before surgery

Outcome Measures

Primary Outcome Measures :

1. postoperative pain [ Time Frame: 24 hours after surgery ]
   use Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain
2. postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor [ Time Frame: first night before surgery ]
   use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)
3. postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor [ Time Frame: first night after surgery ]
   use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)
4. postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor [ Time Frame: third night after surgery ]
   use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

Secondary Outcome Measures :

1. postoperative adverse effects [ Time Frame: 24 hours after surgery ]
   evaluate postoperative adverse effects

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Bijia Song, principal investigator, Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT04627779
• Other Study ID Numbers: Sex difference and pain
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Flurbiprofen; Flurbiprofen axetil; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action