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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
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preemptive Analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    November 4, 2020
    Last Updated
    November 6, 2020
    Sponsor
    Beijing Friendship Hospital
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    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

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

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