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

Y

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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