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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04350086

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection Sars-cov-2 Respiratory Failure Palliative Situation	Drug: Treatment with Dexmedetomidine	Phase 4

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Apr 20, 2020

Anticipated Primary Completion Date :

Nov 20, 2020

Anticipated Study Completion Date :

Nov 20, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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