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

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

Study Overview

• Status: Unknown
• Conditions: Organ Protection
• Intervention / Treatment: Other: normal saline; Drug: dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: dexmedetomidine; 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
Placebo Comparator: Placebo; 25 patients receive matching placebo （normal saline）	Other: normal saline; receive matching placebo (equal volume of normal saline)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: Zhang Yonghai, General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: dexmedetomidine; sepsis; respiration
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: XM2015071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO