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

University of Limoges (UL)

Status and phase: Withdrawn; Phase 4

Conditions: Respiratory Failure; Palliative Situation; Sars-cov-2; COVID-19 Infection

Treatments: Drug: Treatment with Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04350086

87RI20_0011 (PRODEX)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Experimental arm

Experimental group

Treatment:

Drug: Treatment with Dexmedetomidine