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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1
Department of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
Ústí nad Labem, Czechia, 40011