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

Study Overview
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Brief Summary
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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)

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

Conditions
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Acute Respiratory Distress Syndrome, COVID19 Infection

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEVOFLURANE Group<br> | Drug: Sevoflurane<br>* 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)<br>|
| Active Comparator: PROPOFOL Group<br> | Drug: Propofol<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 | 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 | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNFα | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 | 
| IL-1b | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 | 
| IL-6 | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 | 
| IL-8 | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 | 
| Mortality | To evaluate the 30-day mortality. | Day 30 |