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

NCT04529187 | Completed Phase 4

• 1 other identifier: Masaryk Hospital
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Function; Sedation; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 minutes following sedation administration.

Study Arms (2)

DEX group

ACTIVE COMPARATOR

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

MID group

ACTIVE COMPARATOR

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

Interventions

Midazolam DRUG

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)

MID group

Dexmedetomidine DRUG

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)

DEX group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Atrial fibrilation
• Claustrophobia
• Heart Failure
• Renal Failure
• Hepatic disease
• Respiratory insufficiency
• Fertility and lactation
• Patients who cannot cooperate or refuse to sign the consent.

Sponsors & Collaborators

• Masaryk Hospital Krajská zdravotní a.s.: lead

Study Sites (1)

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

Ústí nad Labem, 40011, Czechia

Location

MeSH Terms

Interventions

Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Nedal Omran, M.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

CZ (1)