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

NCT ID: NCT02678728

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Song

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2015-0252

Identifier Type: -

Identifier Source: org_study_id

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