Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.
Condition: Cardiac Function; Sedation; Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 4

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      unpublished, pilot study assured that a number of 15 participants in each arm is sufficient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.

      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.
    

Intervention name(s): Midazolam; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.; To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.
Other intervention name(s): Dormicum® (Roche, F. Hoffmann-La Roche Ltd Basel, Switzerland); Dexdor® (Orion Corporation, Nasdaq OMX Helsinki: ORNAV and ORNBV, Finland)
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care