Overview

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