Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.

Detailed Description
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Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.

Official Title
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Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

Conditions
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Organ Protection

Intervention / Treatment
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* Drug: dexmedetomidine
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with sepsis requiring abdominal cleaning focus of infection older than 18 years American Society of Anesthesiologists (ASA) physical status II-IV. Exclusion Criteria: Bradycardia Atrioventricular block Allergic to the drugs A history of respiratory disease Pregnancy or breast-feeding women

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery | Drug: dexmedetomidine<br>* receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery<br>|
| Placebo Comparator: Placebo<br>25 patients receive matching placebo （normal saline） | Other: normal saline<br>* receive matching placebo (equal volume of normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Alveolar-Arterial Oxygen Difference | Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer. | Before anesthesia | 
| The Oxygenation Index | Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer. | Before anesthesia | 
| The Respiratory Index | Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer. | Before anesthesia | 
| The Alveolar-Arterial Oxygen Difference | Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer. | At 3 minutes after the skin is sutured | 
| The Oxygenation Index | Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer. | At 3 minutes after the skin is sutured | 
| The Respiratory Index | Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer. | At 3 minutes after the skin is sutured | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly | Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the serum tumor necrosis factor-α，which were analyzed by using enzyme linked immunosorbent assay (ELISA). | Before anesthesia and at 3 minutes after the skin is sutured | 
| Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly | Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the interleukin-1β，which were analyzed by using enzyme linked immunosorbent assay (ELISA). | Before anesthesia and at 3 minutes after the skin is sutured | 
| Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly | Arterial blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the lactic acid by using blood gas analyzer. | Before anesthesia and at 3 minutes after the skin is sutured | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, sepsis, respiration