Back to resultsEffect of Dexamethasone on Postoperative Inflammatory Factors
Primary Purpose
Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexamethasone Injection
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation focused on measuring intravenous dexamethasone, inflammation, QoR15, drainage
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥65years of age
- American Society of Anesthesiologists (ASA) physical status 2-4
- Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia
- Requiring a hospital stay of at least one postoperative night
- A surgical skin incision >5 cm in length or multiple incisions with a total incision length of >5 cm
Exclusion Criteria:·
- Poorly controlled diabetes (HbA1c>9.0%)
- Endovascular procedure with a small (<5 cm length) skin incision Ophthalmic surgery
- Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
- Recent (<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics
- Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)
Sites / Locations
- General Hospital of Ningxia Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group Dexamethasone
Group Saline
Arm Description
Group dexamethasone patients received intravenous injection after anesthesia induction Injection 0.15mg/kg dexamethasone (2ml）
Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia
Outcomes
Primary Outcome Measures
the change of drainage fluid volume
Drainage fluid （ml）was collected and the volume of drainage fluid was recorded
Until the drainage tube was pulled out,
the change of Inflammatory mediators in the drainage fluid
CRP(mg/ L) in postoperative drainage fluid was observed
Secondary Outcome Measures
the change of blood inflammatory mediators
Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery
Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique
After the blood CRP(mg/l)
the change of blood routine white blood cell count
Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery
Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique
After the blood blood routine white blood cell count
Full Information
NCT ID
NCT04981093
First Posted
June 14, 2021
Last Updated
July 27, 2021
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04981093
Brief Title
Effect of Dexamethasone on Postoperative Inflammatory Factors
Official Title
Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University
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
This topic foe randomized prospective study.Detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.
Detailed Description
A total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group C,n=50) and dexamethasone group (group D,n=50). Group D was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. Group C was also intravenously injected with 2ml normal saline after anesthesia induction.On this basis, monitor the main results and secondary results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
intravenous dexamethasone, inflammation, QoR15, drainage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Dexamethasone
Arm Type
Experimental
Arm Description
Group dexamethasone patients received intravenous injection after anesthesia induction
Injection 0.15mg/kg dexamethasone (2ml）
Arm Title
Group Saline
Arm Type
Placebo Comparator
Arm Description
Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Injection
Intervention Description
Intravenous injection after induction of anesthesia
Injection 0.15mg/kg dexamethasone (2ml)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
2ml of normal saline was injected intravenously after induction of anesthesia
Primary Outcome Measure Information:
Title
the change of drainage fluid volume
Description
Drainage fluid （ml）was collected and the volume of drainage fluid was recorded
Until the drainage tube was pulled out,
Time Frame
6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Title
the change of Inflammatory mediators in the drainage fluid
Description
CRP(mg/ L) in postoperative drainage fluid was observed
Time Frame
6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Secondary Outcome Measure Information:
Title
the change of blood inflammatory mediators
Description
Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery
Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique
After the blood CRP(mg/l)
Time Frame
6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Title
the change of blood routine white blood cell count
Description
Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery
Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique
After the blood blood routine white blood cell count
Time Frame
6 hours after surgery， the morning of 1, 2, and 3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients ≥65years of age
American Society of Anesthesiologists (ASA) physical status 2-4
Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia
Requiring a hospital stay of at least one postoperative night
A surgical skin incision >5 cm in length or multiple incisions with a total incision length of >5 cm
Exclusion Criteria:·
Poorly controlled diabetes (HbA1c>9.0%)
Endovascular procedure with a small (<5 cm length) skin incision Ophthalmic surgery
Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
Recent (<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics
Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanxiang Ma
Phone
+86-13519591508
Email
mahanxiang@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31494615
Citation
Corcoran TB, Myles PS, Forbes AB, O'Loughlin E, Leslie K, Story D, Short TG, Chan MT, Coutts P, Sidhu J, Cheng AC, Bach LA, Ho KM; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network. The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study. BMJ Open. 2019 Sep 6;9(9):e030402. doi: 10.1136/bmjopen-2019-030402.
Results Reference
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PubMed Identifier
33951362
Citation
Corcoran TB, Myles PS, Forbes AB, Cheng AC, Bach LA, O'Loughlin E, Leslie K, Chan MTV, Story D, Short TG, Martin C, Coutts P, Ho KM; PADDI Investigators; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australasian Society for Infectious Diseases Clinical Research Network. Dexamethasone and Surgical-Site Infection. N Engl J Med. 2021 May 6;384(18):1731-1741. doi: 10.1056/NEJMoa2028982.
Results Reference
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Effect of Dexamethasone on Postoperative Inflammatory Factors
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