Clinical trial NCT02842437: Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
Official title: Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Organ Protection
Keywords: dexmedetomidine
sepsis
respiration
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Alveolar-Arterial Oxygen Difference
timeFrame: Before anesthesia
measure: The Oxygenation Index
timeFrame: Before anesthesia
measure: The Respiratory Index
timeFrame: Before anesthesia
measure: The Alveolar-Arterial Oxygen Difference
timeFrame: At 3 minutes after the skin is sutured
measure: The Oxygenation Index
timeFrame: At 3 minutes after the skin is sutured
measure: The Respiratory Index
timeFrame: At 3 minutes after the skin is sutured
Secondary outcomes:
measure: Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly
timeFrame: Before anesthesia and at 3 minutes after the skin is sutured
measure: Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly
timeFrame: Before anesthesia and at 3 minutes after the skin is sutured
measure: Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly
timeFrame: Before anesthesia and at 3 minutes after the skin is sutured
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Zhang Yonghai
role: PRINCIPAL_INVESTIGATOR
References: