Preemptive AnalgesiaNCT04627779
Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality
A study testing preemptive analgesia with flurbiprofen axetil in people with Preemptive Analgesia and Sex Difference, run by Beijing Friendship Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Preemptive Analgesia, Sex Difference, Flurbiprofen Axetil
- What is being tested?
- preemptive analgesia with flurbiprofen axetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years;
- American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.
Who cannot join
- 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.
About this study
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
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
- Being tested
- preemptive analgesia with flurbiprofen axetil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive analgesia with flurbiprofen axetilDrug
give flurbiprofen axetil 15 min before surgery
| Study group | Role | What they receive |
|---|---|---|
| Male Group | Experimental | Not described Receives: Drug: preemptive analgesia with flurbiprofen axetil |
| Female Group | Active comparator | Not described Receives: Drug: preemptive analgesia with flurbiprofen axetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: third night after surgery
Secondary outcomes (1)
postoperative adverse effects
evaluate postoperative adverse effects
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive AnalgesiaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bijia Song, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627779
- Sponsor's protocol ID
- Sex difference and pain
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04627779
- Acronym / sponsor ID
- Sex difference and pain
- Conditions
- Preemptive Analgesia, Sex Difference, Flurbiprofen Axetil, Postoperative Pain, Postoperative Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Group | Experimental | Drug: preemptive analgesia with flurbiprofen axetil |
| Female Group | Active comparator | Drug: preemptive analgesia with flurbiprofen axetil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 80 years;
- American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preemptive analgesia with flurbiprofen axetilgive flurbiprofen axetil 15 min before surgery | Drug | Female Group, Male Group |
Primary outcome
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
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)
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)
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)
1 secondary outcome
postoperative adverse effects
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Preemptive Analgesia
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingPhase 4
Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
Post Operative Pain, Orthognathic Surgery
Not yet recruitingObservational study
Preoperative Versus Postoperative Interscalene Block in Arthroscopic Rotator Cuff Repair
Rotator Cuff Tear Repair, Interscalene Blocks
Recruiting
The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery
Loxoprofen Sodium Patch, Local Incision
Not yet recruiting
The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Loxoprofen Sodium Patch
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing preemptive analgesia with flurbiprofen axetil in people with Preemptive Analgesia and Sex Difference, run by Beijing Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.