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

NCT02678728 | Completed Phase 4 DMC

• 1 other identifier: 3-2015-0252
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Changes of lung oxygenation from baseline to 24 hr after reperfusion

  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

  Lung compliance will be displayed on the ventilator

  after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Dexmedetomidine DRUG

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

Also known as: precedex

Dexmedetomidine

normal saline DRUG

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

Normal saline

Eligibility Criteria

• Age: 20 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age

You may not qualify if:

• Unstable vital sign before surgery
• Severe pulmonary disease requiring consistent treatment
• Illiterate
• Pregnancy

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: March 30, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)