Effect of Dexamethasone on Postoperative Inflammatory Factors

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery

Conditions
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Inflammation

Intervention / Treatment
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* Drug: Dexamethasone Injection
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Dexamethasone<br>Group dexamethasone patients received intravenous injection after anesthesia induction Injection 0.15mg/kg dexamethasone (2ml） | Drug: Dexamethasone Injection<br>* Intravenous injection after induction of anesthesia Injection 0.15mg/kg dexamethasone (2ml)<br>|
| Placebo Comparator: Group Saline<br>Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia | Drug: Normal saline<br>* 2ml of normal saline was injected intravenously after induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, | 6 hours after surgery， the morning of 1, 2, and 3 days after surgery | 
| the change of Inflammatory mediators in the drainage fluid | CRP(mg/ L) in postoperative drainage fluid was observed | 6 hours after surgery， the morning of 1, 2, and 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 hours after surgery， the morning of 1, 2, and 3 days after surgery | 
| 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 | 6 hours after surgery， the morning of 1, 2, and 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous dexamethasone, inflammation, QoR15, drainage