Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection (PRODEX)
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ClinicalTrials.gov Identifier: NCT04350086 |
Recruitment Status :
Withdrawn
(unfavorable opinion of the ethics committee)
First Posted : April 16, 2020
Last Update Posted : September 2, 2020
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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.
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
University Hospital | |
Limoges, France, 87200 |
Responsible Party: | University Hospital, Limoges |
ClinicalTrials.gov Identifier: | NCT04350086 |
Other Study ID Numbers: |
87RI20_0011 (PRODEX) |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 sars-cov-2 infection respiratory failure palliative situation |
Infections Communicable Diseases COVID-19 Respiratory Insufficiency Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |