Sedation with sevoflurane versus propofol in patients with Acute Respiratory Distress Syndrome caused by COVID-19 infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001379-34-ES

Enrollment

Registered

2020-04-14

Start date

2020-04-14

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

Acute Respiratory Distress Syndrome caused by COVID19 infection MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862

Interventions

Product Name: SEVOFLURANE Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: SEVOFLURANE CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentration unit: ml millilitre(s

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

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
Main Objective: 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 Objective: - to quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 - evaluate the 30-day mortality.;Primary end point(s): Efficacy will be assessed according to the defined objectives of oxygenation, reduction of inflammatory markers;Timepoint(s) of evaluation of this end point: 2 days - PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2.	—

Measure

Time frame

Main Objective: 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 Objective: - to quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 - evaluate the 30-day mortality.;Primary end point(s): Efficacy will be assessed according to the defined objectives of oxygenation, reduction of inflammatory markers;Timepoint(s) of evaluation of this end point: 2 days - PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2.

—

Secondary

Measure	Time frame
Secondary end point(s): 30-day mortality.;Timepoint(s) of evaluation of this end point: Day 30	—

Countries

Spain

Contacts

Public ContactSubdirectora Científica

Instituto de Investigación Sanitaria INCLIVA

gestioncientifica@incliva.es0034961973536

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026