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

NCT04627779 | Unknown

• 1 other identifier: Sex difference and pain
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• postoperative pain

  use Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain

  24 hours after surgery

• postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor

  use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

  first night before surgery

• postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor

  use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

  first night after surgery

• postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor

  use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)

  third night after surgery

Secondary Outcomes (1)

• postoperative adverse effects

  24 hours after surgery

Study Arms (2)

Male Group

EXPERIMENTAL

Drug: preemptive analgesia with flurbiprofen axetil

Female Group

ACTIVE COMPARATOR

Drug: preemptive analgesia with flurbiprofen axetil

Interventions

preemptive analgesia with flurbiprofen axetil DRUG

give flurbiprofen axetil 15 min before surgery

Female Group; Male Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

flurbiprofen axetil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 13, 2020
• Study Start: January 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11