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

Phase 4

Withdrawn

• Conditions: COVID-19 Infection; Sars-cov-2; Respiratory Failure; Palliative Situation
• Interventions: Drug: Treatment with Dexmedetomidine

• Registration Number: NCT04350086
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-16
• Study Start: 2020-04-20
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Treatment with Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France