Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality
Primary Purpose
Preemptive Analgesia, Sex Difference, Flurbiprofen Axetil
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preemptive analgesia with flurbiprofen axetil
Sponsored by
About this trial
This is an interventional treatment trial for Preemptive Analgesia
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 80 years;
- American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Male Group
Female Group
Arm Description
Outcomes
Primary Outcome Measures
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
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)
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)
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)
Secondary Outcome Measures
postoperative adverse effects
evaluate postoperative adverse effects
Full Information
NCT ID
NCT04627779
First Posted
November 4, 2020
Last Updated
November 6, 2020
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04627779
Brief Title
Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preemptive Analgesia, Sex Difference, Flurbiprofen Axetil, Postoperative Pain, Postoperative Sleep Quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Male Group
Arm Type
Experimental
Arm Title
Female Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
preemptive analgesia with flurbiprofen axetil
Intervention Description
give flurbiprofen axetil 15 min before surgery
Primary Outcome Measure Information:
Title
postoperative pain
Description
use Visual analogue scale (VAS) score to evaluate postoperative pain,0 was considered painless, and a score of 10 was considered as intense pain
Time Frame
24 hours after surgery
Title
postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
Description
use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)
Time Frame
first night before surgery
Title
postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
Description
use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)
Time Frame
first night after surgery
Title
postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep) tested by Portable Sleep Monitor
Description
use sleep monitor to evaluate postoperative sleep distribution (Rapid eye movement, unstable sleep and stable sleep)
Time Frame
third night after surgery
Secondary Outcome Measure Information:
Title
postoperative adverse effects
Description
evaluate postoperative adverse effects
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 80 years;
American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality
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