Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection (PRODEX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04350086|
Recruitment Status : Withdrawn (unfavorable opinion of the ethics committee)
First Posted : April 16, 2020
Last Update Posted : September 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Infection Sars-cov-2 Respiratory Failure Palliative Situation||Drug: Treatment with Dexmedetomidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||November 20, 2020|
|Estimated Study Completion Date :||November 20, 2020|
|Experimental: Experimental arm||
Drug: Treatment 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.
- Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine. [ Time Frame: Day 30 ]Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
- Overall survival of patients on Dexmedetomidine [ Time Frame: Day 30 ]Overall survival time in days from inclusion.
- Daily analgesic effect of Dexmedetomidine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 30 ]Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350086
|Limoges, France, 87200|