The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed. The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia. Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
liquid, mg/kg.h, titrated after EEG
liquid, mg/kg.h, titrated after EEG
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Inselspital
Bern, Canton of Bern, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
Refractory Status Epilepticus Controlled With First Course of Study Drug
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
Time frame: after return of continuous EEG activity (typically after 36 hours - 5 days)
Clinical Outcome at Day 21
Return to baseline clinical conditions (i.e.: no new handicap, no death)
Time frame: 21 days
Patients With Infectious Complications Requiring Specific Treatment
Time frame: 10 days
Patients With Hypotension Requiring Specific Treatment
Time frame: 10 days
Patients With Propofol Infusion Syndrome
Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.
Time frame: 10 days
Intubation Time in Survivors
Time frame: Up to 3 months
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Hôpitaux Universitaires de Genève
Geneva, Switzerland