Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in cardiac output following sedation administration
Study Overview
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 participant will be allocated by the envelop method into the dexmedetomidine (DEX) group or into the midazolam (MID) group.
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 inclusion criteria. A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%. After signing the informed consent, a one-session cardiac MRI will be performed in each fasting participant before and after sedation administration (see arms and intervention). The following parameters will be recorded: end diastolic and end systolic volume, left and right ventricle stroke volume and flow velocity through the mitral valve during early and late diastole. A monitor will record values of mean blood pressure, pulse and blood oxygen saturation in 5-minute intervals.
The acquired data will be transferred to an offline workstation for postprocessing and quantification. In participants we will calculate left ventricular volumes using the well-known Simpson's formula by segmenting of endocardial borders on end-diastolic and end-systolic frames on every slice through the left ventricle.
The quantitative flow measurement will be performed using phase contrast quantification flow mapping.
Statistical analyses will be performed using STATISTICA software (data analysis software system, version 13 TIBCO Software Inc). All values will be presented as average ± standard deviation. Analysis of variance for repeated measures with post hoc Fisher's LSD test will be used for statistical testing of significant differences in each group and between the groups before and after sedation, respectively. Significance level will be accepted at α<0.05.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •Atrial fibrilation
- •Claustrophobia
- •Heart Failure
- •Renal Failure
- •Hepatic disease
- •Respiratory insufficiency
- •Fertility and lactation
- •Patients who cannot cooperate or refuse to sign the consent.
Arms & Interventions
MID group
Participants allocated into this arm will undergo a baseline cardiac MRI. Then a single dose of midazolam (2 mg intravenously) will be given to each participant in this arm. After 5 minutes of midazolam administration a control cardiac MRI will be performed to detect changes in heart function following sedation administration.
Intervention: Midazolam (Drug)
DEX group
Participants allocated into this arm will undergo a baseline cardiac MRI. Then a dexmedetomidine infusion in a rate of of 0.7 ug.kg-1.hr-1will be initiated. After 5 minutes of dexmedetomidine therapy a control cardiac MRI will be performed to detect changes in heart function following sedation administration.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Changes in cardiac output following sedation administration
Time Frame: 5 minutes following sedation administration.
Using cardiac MRI stroke volume (measured in mL) of both heart ventricles will be registered prior and after sedation administration.
Changes in diastolic heart function following sedation administration
Time Frame: 5 minutes following sedation administration.
Using cardiac MRI maximum flow velocity through the mitral valve (measured in mL/s) during early and late diastole will be measured prior and after sedation administration.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nedal Omran
MD
Masaryk Hospital Krajská zdravotní a.s.