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Study on Fast Sedation with Propofol and Midazolam vs. Anti-Seizure Drug Combination for Treating Refractory Status Epilepticus in Intensive Care Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as status epilepticus, which is a severe and prolonged seizure that can be life-threatening. The study aims to compare two different treatment approaches for this condition. One approach involves using high doses of medications that help control seizures, known as antiseizure medications. The specific medications being studied include Levetiracetam, Sodium Valproate, Fosphenytoin Sodium, Topiramate, Lacosamide, and Brivaracetam. These medications are administered intravenously, meaning they are given directly into a vein. The other approach involves using medications for rapid sedation, which help calm the brain and body. The medications used for sedation in this study are Propofol and Midazolam, also given intravenously.

The purpose of the study is to determine the effectiveness of rapid sedation with Propofol or Midazolam in an intensive care setting compared to intravenous antiseizure treatment in a hospital ward for patients with a specific type of status epilepticus that is resistant to initial treatments. This type of status epilepticus is referred to as non-convulsive status epilepticus, where the seizures are not accompanied by the typical convulsions or shaking. The study will involve monitoring patients over a period to see how well each treatment works in stopping the seizures and to observe any side effects or complications that may arise.

Participants in the study will receive either the antiseizure medications or the sedation medications, and their progress will be closely monitored by medical professionals. The study will assess various outcomes, such as the number of patients whose seizures continue after 24 hours, any new neurological issues that arise, the length of hospital stay, and overall survival rates after treatment. The goal is to find the most effective and safe treatment option for managing this serious condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to be an adult over 18 years old with a specific type of seizure condition known as non-convulsive status epilepticus (NKSE).

    The patient has not responded to initial treatments, including benzodiazepines and at least one second-line intravenous anti-seizure medication such as levetiracetam, fosphenytoin sodium, or sodium valproate.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two treatment groups: one receiving fast sedation with propofol or midazolam in an intensive care setting, and the other receiving high-dose intravenous anti-seizure medication in a hospital ward.

  3. Step 3

    Treatment administration

    If assigned to the sedation group, the patient receives propofol or midazolam intravenously to achieve rapid sedation.

    If assigned to the anti-seizure medication group, the patient receives high doses of intravenous anti-seizure medications, which may include levetiracetam, sodium valproate, fosphenytoin sodium, topiramate, lacosamide, or brivaracetam.

  4. Step 4

    Monitoring and evaluation

    The patient's condition is monitored for 24 hours to assess the effectiveness of the treatment in controlling the seizures.

    The primary goal is to determine the number of patients who continue to experience NKSE after 24 hours, which is considered a treatment failure.

  5. Step 5

    Follow-up assessments

    Secondary assessments include evaluating any new neurological deficits at discharge, the duration of NKSE, time spent in the intensive care unit, and the number of infections during the hospital stay.

    Additional evaluations include survival rates at 3, 6, 12, and 24 months after randomization, as well as quality of life after discharge.

Who can join the trial?

5 criteria

  • Adults who are older than 18 years.
  • Patients with **EEG-verified** NKSE according to the Salzburg criteria. **EEG** is a test that measures electrical activity in the brain.
  • Patients who have a clear **status epilepticus** with minor motor symptoms after a generalized tonic/clonic seizure. **Status epilepticus** is a condition where a person has a long-lasting seizure.
  • Patients who have not responded to appropriate treatment with **benzodiazepines** and at least one second-line intravenous anti-epileptic medication. **Benzodiazepines** are a type of medication used to calm the brain.
  • The second-line medications include Levetiracetam, Fosfenytoin, or Valproate, according to the current national neurological treatment guidelines.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing status epilepticus. This is a condition where a person has a long-lasting seizure or multiple seizures without regaining full consciousness in between.
  • Patients who are not in the age range of 3 to 4 years old.
  • Patients who are not part of the specific clinical trial group being studied.
  • Patients who are not considered part of a vulnerable population. This means individuals who might need special protection or care.
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Investigated drugs

  • Propofol

    is a medication used to induce sedation in patients. In this trial, it is used to provide fast sedation for patients in intensive care who are experiencing non-convulsive status epilepticus. It helps to calm the brain and reduce seizure activity.

  • Midazolam

    is another sedative used in this trial. Like propofol, it is administered to patients in intensive care to quickly sedate them and manage non-convulsive status epilepticus. It works by slowing down brain activity to help control seizures.

  • Anti-Seizure Medication

    is used in this trial to treat patients with non-convulsive status epilepticus. These medications are given intravenously and work by stabilizing electrical activity in the brain to prevent seizures. The specific anti-seizure medications used in the trial are not named, but they are administered in high doses to effectively manage the condition.

What is already known about the treatment

  • Propofol

    Propofol is administered intravenously and is commonly used in hospital settings, particularly in intensive care units. It is currently well-established in medical practice and literature as a sedative agent. The main therapeutic indication for propofol in this context is to provide rapid sedation for patients experiencing status epilepticus, a severe form of seizure. At the molecular level, propofol works by enhancing the activity of the neurotransmitter GABA, which inhibits nerve transmission in the brain, leading to sedation. It is classified pharmacologically as a general anesthetic.

  • Midazolam

    Midazolam is also administered intravenously and is widely used in medical settings for its sedative properties. It is recognized in medical literature as an effective sedative and anxiolytic. In the treatment of status epilepticus, midazolam is used to quickly sedate patients. Its mechanism of action involves enhancing the effect of the neurotransmitter GABA in the brain, which helps to calm the nervous system. Midazolam is classified as a benzodiazepine, a class of drugs known for their sedative and anti-anxiety effects.

Investigated diseases

Status Epilepticus – Status epilepticus is a serious neurological condition characterized by prolonged or repeated seizures without recovery between them. It occurs when the brain is in a state of persistent seizure activity, typically lasting more than five minutes. This condition can arise from various causes, including brain injury, infections, or withdrawal from certain medications. During status epilepticus, the brain's electrical activity becomes abnormal, leading to continuous convulsions or non-convulsive seizures. If not managed promptly, it can lead to significant neurological damage. The condition requires immediate medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515507-18-00Estimated enrolment154 patientsSponsorOdense University Hospital

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