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

Dissecting Aneurysm of the Thoracic Aorta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678728
• Other study ID #: 3-2015-0252
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: August 2019
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 98 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm, Thoracic
• Chronic Dissecting Aneurysm of Thoracic Aorta
• Chronic Nontraumatic Dissection of Thoracic Aorta
• Dissecting Aneurysm of the Thoracic Aorta
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of lung oxygenation from baseline to 24 hr after reperfusion	Lung oxygenation will be assessed by arterial blood gas analysis	after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Primary	Changes of lung compliance from baseline to 24 hr after reperfusion	Lung compliance will be displayed on the ventilator	after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr