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

NCT ID: NCT04350086

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Infection Sars-cov-2 Respiratory Failure Palliative Situation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

Treatment with Dexmedetomidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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87RI20_0011 (PRODEX)

Identifier Type: -

Identifier Source: org_study_id

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