Treatment of Refractory Status Epilepticus

Mass General Brigham

Status and phase: Terminated; Phase 3

Conditions: Status Epilepticus

Treatments: Drug: propofol; Drug: thiopental/pentobarbital

Study type: Interventional

Funder types: Other

Identifiers

NCT00265616

RSE study, protocol#62/06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: propofol

2

Active Comparator group

Description:

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

Treatment:

Drug: thiopental/pentobarbital