Effect of Midazolam & Dexmedetomidine on Heart Function

Status Completed

Clinical Trial 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.

Clinical Trial 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 A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%.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.

The participants will be monitored during sedation administration and 6 hours following sedation cessation to avoid complications that could be associated with sedation administration such as hypotension or rhythm disturbances. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04529187
Study type	Interventional
Source	Masaryk Hospital Krajská zdravotní a.s.
Contact
Status	Completed
Phase	Phase 4
Start date	January 1, 2018
Completion date	December 31, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms