CClinicalTrials.gg
Status unknownNCT02842437Updated Jul 22, 2016

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

An interventional study of dexmedetomidine and normal saline in Organ Protection, sponsored by General Hospital of Ningxia Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Organ Protection

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Keywords

  • dexmedetomidine
  • sepsis
  • respiration
03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 50 is below the median of 105 across 893 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Placebo

    25 patients receive matching placebo (normal saline)

    Other: normal saline

Interventions

  • Drugdexmedetomidine

    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

  • Othernormal saline

    receive matching placebo (equal volume of normal saline)

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What researchers measure

Primary outcomes

  1. The Alveolar-Arterial Oxygen Difference

    Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.

    Time frame: Before anesthesia

  2. The Oxygenation Index

    Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.

    Time frame: Before anesthesia

  3. The Respiratory Index

    Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.

    Time frame: Before anesthesia

  4. 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.

    Time frame: At 3 minutes after the skin is sutured

  5. 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.

    Time frame: At 3 minutes after the skin is sutured

  6. 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.

    Time frame: At 3 minutes after the skin is sutured

Secondary outcomes

  1. 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).

    Time frame: Before anesthesia and at 3 minutes after the skin is sutured

  2. 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).

    Time frame: Before anesthesia and at 3 minutes after the skin is sutured

  3. 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.

    Time frame: Before anesthesia and at 3 minutes after the skin is sutured

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Study locations

1 site
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842437
Lead sponsor
General Hospital of Ningxia Medical University
Responsible party
Sponsor
First posted
Jul 22, 2016
Start date
Jul 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jul 22, 2016

Study contacts

Ma Hanxiang
Contact
mahanxiang@hotmail.com
+86-13519591508
Zhang Yonghai
Contact
zhangyongha@hotmail.com
+86-15909508072
Zhang Yonghai
principal investigator · General Hospital of Ningxia Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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