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

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ClinicalTrials.gov Identifier: NCT02678728
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Young Song, Gangnam Severance Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Dissecting Aneurysm of Thoracic Aorta Chronic Nontraumatic Dissection of Thoracic Aorta Dissecting Aneurysm of the Thoracic Aorta Drug: Dexmedetomidine Drug: normal saline Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Study Start Date : February 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off
Drug: Dexmedetomidine
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off
Other Name: precedex

Placebo Comparator: Normal saline
IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off
Drug: normal saline
IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off




Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678728


Locations
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Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Gangnam Severance Hospital

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Responsible Party: Young Song, Associate Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02678728     History of Changes
Other Study ID Numbers: 3-2015-0252
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aortic Diseases
Analgesics, Non-Narcotic
Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action