Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04611763
Collaborator
(none)
100
1
2
9.9
10.1

Study Details

Study Description

Brief Summary

In humans and animals, circadian rhythm sleep cycle is an important function to maintain and regulate 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". However, previous studies have shown that 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 vomitting etc after general anesthesia may also reduce postoperative sleep quality.Meanwhile, there is a mixed literature linking sleep and markers of systemic inflammation that greater sleep disturbances were associated with higher levels of circulating IL-6 and CRP but not TNF-α. And the effects of inflammatory cytokines may also cause changes in sleep patterns. Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids. It not only has a high affnity for infammatory tissues to achieve targeted drug therapy and prolonged duration of action, but causes analgesia effect through decreasing the biological production of prostaglandins, reducing the reactivity of peripheral nerves to endogenous infammatory factors, and inhibiting the sensitization of central as well as peripheral nervous systems.Furthermore, it could also inhibite 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 the use of local anesthetics and/or analgesics in advance can prevent central nervous system hyperplasia, thereby reducing postoperative pain. The aim of our study was to investigate the effect of preemptive analgesic with flurbiprofen axetil on postoperative pain, inflammatory markers and sleep quality among patients under general anesthesia. We hypothesized that use flurbiprofen axetil preoperatively would effectively relieve postoperative pain, inhibite inflammtory reaction and improve postoperative sleep quality.

Condition or Disease Intervention/Treatment Phase
  • Drug: Flurbiprofen axetil preoperatively
  • Drug: Flurbiprofen axetil postoperatively
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pre FA Group

Drug: Flurbiprofen axetil preoperatively
give Flurbiprofen axetil 15 min before surgery

Active Comparator: Post FA Group

Drug: Flurbiprofen axetil postoperatively
give Flurbiprofen axetil at the end of surgery

Outcome Measures

Primary Outcome Measures

  1. Postoperative 24 hours pain score [24 hours after surgery]

    Use VAS to evaluated postoperative pain score

  2. perioperative inflammatory markers [the day before surgery]

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

  3. perioperative inflammatory markers [first day after surgery]

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

  4. perioperative inflammatory markers [third day after surgery]

    The inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR) and c-reactive protein (CRP) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

Secondary Outcome Measures

  1. preoperative sleep quality [the first night before surgery]

    evaluate postoperative sleep quality at the first night before surgery

  2. postoperative sleep quality [the first night after surgery]

    evaluate postoperative sleep quality at the first night after surgery

  3. postoperative sleep quality [the third night after surgery]

    evaluate postoperative sleep quality at the third night after surgery

  4. postoperative adverse effects [24 hours after surgery]

    evaluate postoperative adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

age: 18-75 ASA: I-II Receive operation under general anesthesia

Exclusion Criteria:
  • ①Patients with mental illness;

  • Severe sleep disorders in the past;

  • A history of taking opioids;

  • Patients who are allergic to the drug

  • Patients who have difficulty communicating and refuse to participate in the trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 beijing friendship hospital of Capital Medical university Beijing China

Sponsors and Collaborators

  • Beijing Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bijia Song, principal investigator, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT04611763
Other Study ID Numbers:
  • Flurbiprofen axetil
First Posted:
Nov 2, 2020
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022