Clinical Trials Directory

Trials / Terminated

TerminatedNCT04359862

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGSevoflurane25 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)
DRUGPropofol25 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)

Timeline

Start date
2020-04-16
Primary completion
2021-03-31
Completion
2021-03-31
First posted
2020-04-24
Last updated
2021-07-27

Locations

5 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04359862. Inclusion in this directory is not an endorsement.