COVID-19 Infection, Palliative Situation, Respiratory Failure, Sars-cov-2
Conditions
Keywords
COVID-19, sars-cov-2, infection, respiratory failure, palliative situation
Brief summary
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.
Interventions
DRUGTreatment with Dexmedetomidine
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.
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Major patient 2. Relating to palliative care 3. With sars-cov-2 infection 4. Requiring light to moderate sedation corresponding to a RASS score of -1 to -3
Exclusion criteria
1. Pregnant, lactating woman. 2. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics 3. Advanced heart block (level 2 or 3) unless a pacemaker. 4. Uncontrolled hypotension. 5. Acute cerebrovascular pathologies. 6. Use of other sedative drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine. | Day 30 | Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival of patients on Dexmedetomidine | Day 30 | Overall survival time in days from inclusion. |
| Daily analgesic effect of Dexmedetomidine | Day 30 | The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9. |
| Other sedative pharmacological agents | Day 30 | Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine. |
| Average dosage required for Dexmedetomidine to achieve mild to moderate sedation | Day 30 | Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation |
Countries
France
Outcome results
None listed