The Effects of Dexmedetomidine on Inflammatory Mediators After One Lung Ventilation During Video-assisted Thoracoscopic Surgery
NCT ID: NCT02439905
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2015-05-31
2016-05-31
Brief Summary
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Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine decreased reperfusion injury, reduce the release of proinflammatory mediator and protected lungs from reperfusion injury in esophageal cancer patients who undergoing one lung ventilation from reducing oxidative stress metabolites. However, other details of protective effects is still unknown.
High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be related to ventilator induced lung injury in several condition. Animal studies also showed that dexmedetomidine reduces the expression of messenger ribonucleic acid in lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release. However, clinical trials about these are still lacking.
In this study, we will investigate the protective effects of dexmedetomidine to patients undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6). This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of further medical therapy in treating inflammation.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexmedetomidine group
Dexmedetomidine
In dexmedetomidine group, dexmedetomidine infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
Normal saline group
Placebo control
In normal saline group, normal saline infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
Interventions
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Dexmedetomidine
In dexmedetomidine group, dexmedetomidine infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
Placebo control
In normal saline group, normal saline infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
Eligibility Criteria
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Inclusion Criteria
2. Patients with the following will be excluded:
* suspect of infection, eg. white blood cell count\> 10000 ; fever\> 38.3℃
* preoperative cardiac or renal dysfunction, eg. New York Heart Association \>= II, estimated glomerular filtration rate\< 60
* predisposing liver dysfunction, eg. aspartate aminotransferase or alanine aminotransferase \>100; total bilirubin\> 2mg/dl; \>= Child B liver cirrhosis
20 Years
75 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chun-Yu Wu
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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201410035MINC
Identifier Type: -
Identifier Source: org_study_id