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

NCT ID: NCT04529187

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-31

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 A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%.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

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.

Conditions

Cardiac Function; Sedation; Magnetic Resonance Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.

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.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.

Interventions

Midazolam

To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.

Intervention Type: DRUG

Dexmedetomidine

To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.

Intervention Type: DRUG

Other Intervention Names

Dormicum® (Roche, F. Hoffmann-La Roche Ltd Basel, Switzerland); Dexdor® (Orion Corporation, Nasdaq OMX Helsinki: ORNAV and ORNBV, Finland)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masaryk Hospital Krajská zdravotní a.s.

OTHER

Sponsor Role: lead

Responsible Party

Nedal Omran

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nedal Omran, M.D

Role: PRINCIPAL_INVESTIGATOR

Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.

Locations

Department of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.

Ústí nad Labem, , Czechia

Countries

Czechia

Other Identifiers

Masaryk Hospital

Identifier Type: -

Identifier Source: org_study_id