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NCT Number: NCT02439905

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

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.

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Key information

Conditions

One Lung Ventilation in Thoracic Surgery

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

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.

Primary outcomes

  1. Postoperative plasma level of HMGB1

    Time frame: 2 days

Secondary outcomes

  1. Postoperative complications

    Time frame: during hospital stay, an expected average of one week

Other outcomes

  1. Postoperative pain score

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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