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

Terminated
Acute Respiratory Distress Syndrome
COVID19 Infection

Drug: Sevoflurane

25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

Drug: Propofol

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)

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
Spain
Locations

Hospital Universitario Cruces
Barakaldo, Bizkaia, Spain

Hospital Universitario Ramón y Cajal
Madrid, Spain

Hospital Universitario La Paz
Madrid, Spain

Hospital Clínico Universitario de Valencia
Valencia, Spain

Hospital General Universitario de Valencia
Valencia, Spain

Fundación para la Investigación del Hospital Clínico de Valencia
NCT Number
MeSH Terms
Infections
Communicable Diseases
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Propofol
Sevoflurane