Back to resultsEffect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Primary Purpose
Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Dissecting Aneurysm of Thoracic Aorta
Eligibility 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
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Normal saline
Arm Description
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off
IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off
Outcomes
Primary Outcome Measures
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Lung oxygenation will be assessed by arterial blood gas analysis
Changes of lung compliance from baseline to 24 hr after reperfusion
Lung compliance will be displayed on the ventilator
Secondary Outcome Measures
Full Information
NCT ID
NCT02678728
First Posted
January 19, 2016
Last Updated
August 11, 2019
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02678728
Brief Title
Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Official Title
Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off
Primary Outcome Measure Information:
Title
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Description
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
Title
Changes of lung compliance from baseline to 24 hr after reperfusion
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
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