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

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02678728

Collaborator

(none)

Enrollment

Location

Arms

25.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Dissecting Aneurysm of Thoracic Aorta Chronic Nontraumatic Dissection of Thoracic Aorta Dissecting Aneurysm of the Thoracic Aorta	Drug: Dexmedetomidine Drug: normal saline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Feb 28, 2018

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine 1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off	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 Other Names: precedex
Placebo Comparator: Normal saline IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off	Drug: normal saline IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off

Arm

Intervention/Treatment

Experimental: Dexmedetomidine

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

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

Other Names:

precedex

Placebo Comparator: Normal saline

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

Drug: normal saline

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 98 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Young Song, Associate Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT02678728

Other Study ID Numbers:

3-2015-0252

First Posted:

Feb 10, 2016

Last Update Posted:

Aug 14, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Aneurysm, Dissecting

Aneurysm

Aortic Aneurysm, Thoracic

Dexmedetomidine

Study Results

No Results Posted as of Aug 14, 2019