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

Phase 4

Completed

• Conditions: Chronic Dissecting Aneurysm of Thoracic Aorta; Chronic Nontraumatic Dissection of Thoracic Aorta; Dissecting Aneurysm of the Thoracic Aorta
• Interventions: Drug: normal saline; Drug: Dexmedetomidine

• Registration Number: NCT02678728
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-01-19
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Primary Completion: 2018-02-28
• Study Completion: 2018-03-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-11
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	normal saline	IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off
Dexmedetomidine	Dexmedetomidine	1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off

Primary Outcome Measures

Name	Time	Method
Changes of lung oxygenation from baseline to 24 hr after reperfusion	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
Changes of lung compliance from baseline to 24 hr after reperfusion	after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr	Lung compliance will be displayed on the ventilator

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of