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Completed

NCT Number: NCT02678728

Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial

Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.

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Key information

Conditions

Chronic Dissecting Aneurysm of Thoracic Aorta Chronic Nontraumatic Dissection of Thoracic Aorta Dissecting Aneurysm of the Thoracic Aorta

Age range

20 year–98 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam Severance Hospital

Seoul, South Korea

About this study

Patients will be divided into 2 groups; dexmedetomidine group and control group. Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. And control group will receive the same amount of normal saline instead. Analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, The investigators will investigate the protective effect of dexmedetomidine on lung.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age

Exclusion criteria

  • Unstable vital sign before surgery
  • Severe pulmonary disease requiring consistent treatment
  • Illiterate
  • Pregnancy

Treatment and study plan

Dexmedetomidine

Drug

1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off

Other names: precedex

normal saline

Drug

IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off

Primary outcomes

  1. Changes of lung oxygenation from baseline to 24 hr after reperfusion

    Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

    Lung oxygenation will be assessed by arterial blood gas analysis

  2. Changes of lung compliance from baseline to 24 hr after reperfusion

    Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

    Lung compliance will be displayed on the ventilator

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 10, 2016
Registry last updated
Aug 14, 2019

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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