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

• Status: Terminated
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Treatments: Propofol; Sevoflurane

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