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

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 4

Conditions: Chronic Nontraumatic Dissection of Thoracic Aorta; Dissecting Aneurysm of the Thoracic Aorta; Chronic Dissecting Aneurysm of Thoracic Aorta

Treatments: Drug: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02678728

3-2015-0252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 20 to 98 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

52 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off

Treatment:

Drug: Dexmedetomidine

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline