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

NCT ID: NCT04359862

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2021-03-31

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)

Conditions

Acute Respiratory Distress Syndrome; COVID19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEVOFLURANE Group

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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)

PROPOFOL Group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Cruces

Barakaldo, Bizkaia, Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

SEVO-COVID19

Identifier Type: -

Identifier Source: org_study_id