The Effects of Dexmedetomidine on Inflammatory Mediators After One Lung Ventilation During Video-assisted Thoracoscopic Surgery

December 13, 2016 updated by: National Taiwan University Hospital

During lung surgery, mechanical one-lung ventilation is usually mandatory to provide appropriate surgical condition. However, not only mechanical ventilation is associated with inflammatory response, but also one lung ventilation will result in detrimental effects such as ischemia and reperfusion injury, and systemic inflammatory responses.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists physical classification I-II patients who receive VATS lobectomy

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Drug: 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 Comparator: Normal saline group
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative plasma level of HMGB1
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: during hospital stay, an expected average of one week
during hospital stay, an expected average of one week

Other Outcome Measures

Outcome Measure
Time Frame
Postoperative pain score
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201410035MINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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