Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678728
Enrollment
52
Registered
2016-02-10
Start date
2016-02-29
Completion date
2018-03-30
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta

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.

Interventions

DRUGDexmedetomidine

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

DRUGnormal saline

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

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 98 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of lung oxygenation from baseline to 24 hr after reperfusionafter induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hrLung oxygenation will be assessed by arterial blood gas analysis
Changes of lung compliance from baseline to 24 hr after reperfusionafter induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hrLung compliance will be displayed on the ventilator

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026