A Phase 4 interventional study of Midazolam and Dexmedetomidine in Cardiac Function, Sedation and Magnetic Resonance Imaging, sponsored by Masaryk Hospital Krajská zdravotní a.s.. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Masaryk Hospital Krajská zdravotní a.s. · Phase 4, Interventional, and Supportive care
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.
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 A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%.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.
Masaryk Hospital Krajská zdravotní a.s. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexmedetomidine
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.
Drug: Midazolam
To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.
Also known as: Dormicum® (Roche, F. Hoffmann-La Roche Ltd Basel, Switzerland)
To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.
Also known as: Dexdor® (Orion Corporation, Nasdaq OMX Helsinki: ORNAV and ORNBV, Finland)
Changes in cardiac output following sedation administration
Using cardiac MRI stroke volume (measured in mL) of both heart ventricles will be registered prior and after sedation administration.
Time frame: 5 minutes following sedation administration.
Changes in diastolic heart function 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.
Time frame: 5 minutes following sedation administration.
Ran from Jan 2018 to primary completion in Dec 2019, 23 months.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Midazolam · Dexmedetomidine
Masaryk Hospital Krajská zdravotní a.s.