Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

Study Overview
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Brief Summary
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The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

Official Title
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Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

Conditions
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COVID-19 Infection, Sars-cov-2, Respiratory Failure, Palliative Situation

Intervention / Treatment
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* Drug: Treatment with Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient Relating to palliative care With sars-cov-2 infection Requiring light to moderate sedation corresponding to a RASS score of -1 to -3 Exclusion Criteria: Pregnant, lactating woman. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics Advanced heart block (level 2 or 3) unless a pacemaker. Uncontrolled hypotension. Acute cerebrovascular pathologies. Use of other sedative drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br> | Drug: Treatment with Dexmedetomidine<br>* Administration of Dexmedetomidine in continuous infusion by electric syringe pump at a dose of 0.4 µg / kg / h, with dose adjustment according to the sedation score and tolerance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine. | Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of patients on Dexmedetomidine | Overall survival time in days from inclusion. | Day 30 | 
| Daily analgesic effect of Dexmedetomidine | The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9. | Day 30 | 
| Other sedative pharmacological agents | Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine. | Day 30 | 
| Average dosage required for Dexmedetomidine to achieve mild to moderate sedation | Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, sars-cov-2, infection, respiratory failure, palliative situation