Treatment of Refractory Status Epilepticus

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

liquid, mg/kg.h, titrated after EEG

2

thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined

Group Type ACTIVE_COMPARATOR

thiopental/pentobarbital

Intervention Type DRUG

liquid, mg/kg.h, titrated after EEG

Interventions

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propofol

liquid, mg/kg.h, titrated after EEG

Intervention Type DRUG

thiopental/pentobarbital

liquid, mg/kg.h, titrated after EEG

Intervention Type DRUG

Other Intervention Names

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Disoprivan Pentotal /Thiopentone

Eligibility Criteria

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Inclusion Criteria

* Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.

Exclusion Criteria

* Age \< 16 years old.
* Known pregnancy.
* Cerebral anoxia as SE etiology.
* Epilepsia partialis continua (simple partial SE).
* Known intolerance to the study drugs.
* Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No