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

NCT04359862 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-07-27

No results posted yet for this study

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)

Conditions

  • Acute Respiratory Distress Syndrome
  • COVID19 Infection

Interventions

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)

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359862 on ClinicalTrials.gov