NCT00265616

Treatment of Refractory Status Epilepticus

A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Status Epilepticus

Interventions

Type	Name	Description
DRUG	propofol	liquid, mg/kg.h, titrated after EEG
DRUG	thiopental/pentobarbital	liquid, mg/kg.h, titrated after EEG

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2005-12-15
• Last updated: 2013-04-09
• Results posted: 2013-04-04

Locations

5 sites across 2 countries: United States, Switzerland