A Phase 4 interventional study of Dexmedetomidine and normal saline in Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta and Dissecting Aneurysm of the Thoracic Aorta, sponsored by Gangnam Severance Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 98 Years. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Gangnam Severance Hospital · Phase 4, Interventional, and Prevention
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.
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.
Gangnam Severance Hospital is the lead sponsor of 145 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off
Drug: Dexmedetomidine
IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off
Drug: normal saline
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off
Also known as: precedex
IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Lung oxygenation will be assessed by arterial blood gas analysis
Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Changes of lung compliance from baseline to 24 hr after reperfusion
Lung compliance will be displayed on the ventilator
Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Plan to share: No
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The record gives a start of Feb 2016, a primary completion of Feb 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine