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

Not Applicable

• Conditions: Organ Protection
• Interventions: Other: normal saline; Drug: dexmedetomidine

• Registration Number: NCT02842437
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-22
• Last Update Posted: 2016-07-22
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

• Bradycardia
• Atrioventricular block
• Allergic to the drugs
• A history of respiratory disease
• Pregnancy or breast-feeding women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	normal saline	25 patients receive matching placebo （normal saline）
Dexmedetomidine	dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
The Oxygenation Index	At 3 minutes after the skin is sutured	Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
The Alveolar-Arterial Oxygen Difference	At 3 minutes after the skin is sutured	Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Respiratory Index	At 3 minutes after the skin is sutured	Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.

Secondary Outcome Measures

Name	Time	Method
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly	Before anesthesia and at 3 minutes after the skin is sutured	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).
Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly	Before anesthesia and at 3 minutes after the skin is sutured	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.
Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly	Before anesthesia and at 3 minutes after the skin is sutured	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).

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China