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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04359862

Acronym

SEVO-COVID19

Enrollment

Registered

2020-04-24

Start date

2020-04-16

Completion date

2021-03-31

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, COVID19 Infection

Brief 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)

Interventions

DRUGSevoflurane

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)

DRUGPropofol

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PaO2/FiO2	Day 2	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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026