Status:

COMPLETED

Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.

Lead Sponsor:

Masaryk Hospital Krajská zdravotní a.s.

Conditions:

Cardiac Function

Sedation

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

To compare the changes in heart function, induced after sedation with midazolam or dexmedetomidine, using cardiac magnetic resonance imaging (MRI). This study is a randomized unmasked study, in which...

Detailed Description

The study will test the hypothesis that the use of dexmedetomidine leads to less negative impact on ventricular function compared to midazolam. The study will include patients who will meet the inclu...

Eligibility Criteria

Inclusion

  • Patients who were admitted due to chest pain, in whom acute coronary syndrome, pulmonary embolism and acute aortic syndrome were ruled out
  • Age ≥18 and ≤ 65 years
  • No contraindication to provide cardiac MRI
  • No known allergy to Midazolam or Dexmedetomidine
  • Signed informed consent
  • No history of heart, hepatic, renal or respiratory failure

Exclusion

  • Atrial fibrilation
  • Claustrophobia
  • Heart Failure
  • Renal Failure
  • Hepatic disease
  • Respiratory insufficiency
  • Fertility and lactation
  • Patients who cannot cooperate or refuse to sign the consent.

Key Trial Info

Start Date :

January 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2019

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04529187

Start Date

January 1 2018

End Date

December 31 2019

Last Update

August 27 2020

Active Locations (1)

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Department of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.

Ústí nad Labem, Czechia, 40011