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Treatment of Refractory Status Epilepticus

This study has been terminated.
(Insufficient recruitment)
Information provided by (Responsible Party):
Andrea O. Rossetti, MD, Brigham and Women's Hospital Identifier:
First received: December 13, 2005
Last updated: April 2, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Status Epilepticus
Drug: propofol
Drug: thiopental/pentobarbital
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Refractory Status Epilepticus Controlled With First Course of Study Drug [ Time Frame: after return of continuous EEG activity (typically after 36 hours - 5 days) ]
    Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)

Secondary Outcome Measures:
  • Clinical Outcome at Day 21 [ Time Frame: 21 days ]
    Return to baseline clinical conditions (i.e.: no new handicap, no death)

  • 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 [ Time Frame: 10 days ]
    Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.

  • Intubation Time in Survivors [ Time Frame: Up to 3 months ]

Enrollment: 23
Study Start Date: May 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Drug: propofol
liquid, mg/kg.h, titrated after EEG
Other Name: Disoprivan
Active Comparator: 2
thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Drug: thiopental/pentobarbital
liquid, mg/kg.h, titrated after EEG
Other Name: Pentotal /Thiopentone

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.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00265616

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Bern, BE, Switzerland
Lausanne, VD, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Andrea O. Rossetti, MD BrighamHospital/CHUV
  More Information

Responsible Party: Andrea O. Rossetti, MD, Dr, Brigham and Women's Hospital Identifier: NCT00265616     History of Changes
Other Study ID Numbers: RSE study, protocol#62/06
Study First Received: December 13, 2005
Results First Received: October 27, 2010
Last Updated: April 2, 2013

Keywords provided by Brigham and Women's Hospital:
Refractory status epilepticus,

Additional relevant MeSH terms:
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia processed this record on May 23, 2017