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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02842437
Enrollment
50
Registered
2016-07-22
Start date
2016-07-31
Completion date
2017-12-31
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Protection

Keywords

dexmedetomidine, sepsis, respiration

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.

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)

Sponsors

General Hospital of Ningxia Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
The Alveolar-Arterial Oxygen DifferenceBefore anesthesiaArterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Oxygenation IndexBefore anesthesiaArterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.
The Respiratory IndexBefore anesthesiaArterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.

Secondary

MeasureTime frameDescription
Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantlyBefore anesthesia and at 3 minutes after the skin is suturedBlood 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).
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantlyBefore anesthesia and at 3 minutes after the skin is suturedBlood 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 instantlyBefore anesthesia and at 3 minutes after the skin is suturedArterial blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the lactic acid by using blood gas analyzer.

Countries

China

Contacts

Primary ContactMa Hanxiang
mahanxiang@hotmail.com+86-13519591508
Backup ContactZhang Yonghai
zhangyongha@hotmail.com+86-15909508072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026