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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Collaborator: |
University of California, San Francisco |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004297 |
Purpose
OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus.
II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission.
III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
| Condition | Intervention | Phase |
|---|---|---|
|
Status Epilepticus |
Drug: diazepam Drug: lorazepam |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind |
| Estimated Enrollment: | 210 |
| Study Start Date: | November 1995 |
| Estimated Study Completion Date: | February 1999 |
PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center.
Patients en route to the hospital in a San Francisco Department of Health Paramedic Division ambulance are randomly assigned to 1 of 3 treatment groups. Informed consent is waived due to impaired consciousness.
Patients receive intravenous diazepam, lorazepam, or placebo during transport. The patient is re-treated if the seizure is sustained after the first dose or recurs after the first dose without the patient regaining consciousness.
Upon arrival at the hospital, all patients receive the standard status epilepticus treatment in use at that site.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Status epilepticus with at least 5 minutes of sustained seizure activity with a depressed level of consciousness, or 2 or more discrete seizures without recovery or consciousness between seizures Verified by bystander or observed by paramedic from San Francisco Department of Health --Prior/Concurrent Therapy-- No chronic benzodiazepines for seizure disorder --Patient Characteristics-- Cardiovascular: Systolic blood pressure at least 100 mm Hg No second- or third- degree atrioventricular block No sustained ectopic tachyrhythmia Pulse rate between 60 and 150 No severe myocardial insufficiency No hypovolemic, cardiogenic, or obstructive shock Pulmonary: No history of asthma No history of chronic obstructive airway disease No history of limited pulmonary reserve Other: No allergy or prior sensitivity to benzodiazepines No distributive shock (e.g., septic, neurogenic, or anaphylactic)
Contacts and Locations More Information
| Study ID Numbers: | 199/11733, UCSF-69020732504A |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004297 History of Changes |
| Health Authority: | United States: Federal Government |
|
epilepsy neurologic and psychiatric disorders rare disease seizures status epilepticus |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Neuromuscular Agents Brain Diseases Lorazepam Therapeutic Uses Status Epilepticus Muscle Relaxants, Central Hypnotics and Sedatives Anesthetics, Intravenous |
Tranquilizing Agents Diazepam Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Epilepsy Autonomic Agents GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |
