Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection

Fundación para la Investigación del Hospital Clínico de Valencia5 sites in 1 country19 target enrollmentApril 16, 2020

ConditionsAcute Respiratory Distress Syndrome COVID19 Infection

InterventionsSevoflurane Propofol

DrugsSevoflurane Propofol

Overview

Phase: Phase 4
Intervention: Sevoflurane
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Enrollment: 19
Locations: 5
Primary Endpoint: PaO2/FiO2
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.

Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.

Patients will be randomized to one of the treatment groups:

SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

Registry

clinicaltrials.gov

Start Date

April 16, 2020

End Date

March 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or more.
•Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
•Signature of Patient's Consent or Verbal Consent of Legal Representative

Exclusion Criteria

•Intracranial hypertension
•Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
•Current volume \< 250ml
•History of malignant hyperthermia
•Liver failure
•Neutropenia (\<0.5x109)
•Pregnant or lactating women
•Have received chemotherapy in the last month since their inclusion in the study

Arms & Interventions

SEVOFLURANE Group

Intervention: Sevoflurane

PROPOFOL Group

Intervention: Propofol

Outcomes

Primary Outcomes

PaO2/FiO2

Time Frame: Day 2

To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19