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Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection (SEVO-COVID19)

F

Fundación para la Investigación del Hospital Clínico de Valencia

Status and phase

Terminated
Phase 4

Conditions

Acute Respiratory Distress Syndrome
COVID19 Infection

Treatments

Drug: Propofol
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT04359862
SEVO-COVID19

Details and patient eligibility

About

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)

Enrollment

19 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

SEVOFLURANE Group
Experimental group
Treatment:
Drug: Sevoflurane
PROPOFOL Group
Active Comparator group
Treatment:
Drug: Propofol

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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