RecruitingPhase 3NCT05263674

Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)


Sponsor

University of Southern Denmark

Enrollment

140 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rapid sedation for people with non-convulsive status epilepticus. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 120 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRapid sedation

High-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.


Locations(5)

Aarhus Universitetshospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Department of Neurology

Herlev, Denmark

Odense University Hospital

Odense, Denmark

University Hospital of Zealand

Roskilde, Denmark

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NCT05263674