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

August 11, 2019 updated by: Young Song, Gangnam Severance Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Time Frame: 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
after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Changes of lung compliance from baseline to 24 hr after reperfusion
Time Frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Lung compliance will be displayed on the ventilator
after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2015-0252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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