Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Primary Purpose
Flurbiprofen Axetil, Preemptive Analgesia, Postoperative Pain
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Flurbiprofen axetil preoperatively
Flurbiprofen axetil postoperatively
Sponsored by
About this trial
This is an interventional treatment trial for Flurbiprofen Axetil
Eligibility Criteria
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.
Sites / Locations
- beijing friendship hospital of Capital Medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre FA Group
Post FA Group
Arm Description
Outcomes
Primary Outcome Measures
Postoperative 24 hours pain score
Use VAS to evaluated postoperative pain score
perioperative inflammatory markers
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.
perioperative inflammatory markers
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.
perioperative inflammatory markers
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
preoperative sleep quality
evaluate postoperative sleep quality at the first night before surgery
postoperative sleep quality
evaluate postoperative sleep quality at the first night after surgery
postoperative sleep quality
evaluate postoperative sleep quality at the third night after surgery
postoperative adverse effects
evaluate postoperative adverse effects
Full Information
NCT ID
NCT04611763
First Posted
October 29, 2020
Last Updated
December 17, 2021
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04611763
Brief Title
Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Official Title
Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flurbiprofen Axetil, Preemptive Analgesia, Postoperative Pain, Perioperative Sleep Quality, Postoperative Inflammatory Markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre FA Group
Arm Type
Experimental
Arm Title
Post FA Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen axetil preoperatively
Intervention Description
give Flurbiprofen axetil 15 min before surgery
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen axetil postoperatively
Intervention Description
give Flurbiprofen axetil at the end of surgery
Primary Outcome Measure Information:
Title
Postoperative 24 hours pain score
Description
Use VAS to evaluated postoperative pain score
Time Frame
24 hours after surgery
Title
perioperative inflammatory markers
Description
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.
Time Frame
the day before surgery
Title
perioperative inflammatory markers
Description
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.
Time Frame
first day after surgery
Title
perioperative inflammatory markers
Description
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.
Time Frame
third day after surgery
Secondary Outcome Measure Information:
Title
preoperative sleep quality
Description
evaluate postoperative sleep quality at the first night before surgery
Time Frame
the first night before surgery
Title
postoperative sleep quality
Description
evaluate postoperative sleep quality at the first night after surgery
Time Frame
the first night after surgery
Title
postoperative sleep quality
Description
evaluate postoperative sleep quality at the third night after surgery
Time Frame
the third night after surgery
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bijia Song
Phone
+8618309845273
Email
630992254@qq.com
Facility Information:
Facility Name
beijing friendship hospital of Capital Medical university
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijia Song
Phone
+8618309845273
Email
630992254@qq.com
12. IPD Sharing Statement
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Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.
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