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

Respiratory Failure Clinical Trial

— PRODEX  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04350086
• Other study ID #: 87RI20_0011 (PRODEX)
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 20, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19 Infection
• Infection
• Palliative Situation
• Respiratory Failure
• Respiratory Insufficiency
• Sars-cov-2

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival of patients on Dexmedetomidine	Overall survival time in days from inclusion.	Day 30
Secondary	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
Secondary	Other sedative pharmacological agents	Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.	Day 30
Secondary	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