Study on the Effects of Esketamine Hydrochloride and Propofol for Patients After Cardiac Arrest

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What is this study about?

This clinical trial is focused on studying the effects of two medications, esketamine and propofol, in patients who have experienced an out-of-hospital cardiac arrest. An out-of-hospital cardiac arrest occurs when the heart suddenly stops beating outside of a hospital setting, which can lead to serious brain damage if not treated quickly. The purpose of the study is to determine if esketamine can protect the brain better than propofol when used as part of sedation after the heart has been restarted.

Participants in the study will receive either esketamine or propofol through an injection into a vein. This will happen after they have been resuscitated, which means their heart has been restarted, and they need to be sedated for a procedure called intubation. Intubation involves placing a tube into the windpipe to help with breathing. The study will monitor the effects of these medications on the brain and overall recovery.

The trial will measure specific markers in the blood, such as neuron-specific enolase, which can indicate brain injury, 48 hours after the cardiac arrest. Additionally, the study will track the survival of participants and their recovery over several months. This information will help determine which medication might offer better protection for the brain following a cardiac arrest outside of a hospital.

1 initial resuscitation and intubation

Following an out-of-hospital cardiac arrest, initial resuscitation is performed. If the decision is made to perform intubation, or if intubation occurs during cardiopulmonary resuscitation (CPR), sedation is required.

2 administration of study medication

Before arrival at the hospital, the study medication is administered. This involves the use of either esketamine hydrochloride or propofol as part of the sedation process. Both medications are given through an intravenous bolus injection or infusion.

3 monitoring and assessment

Neuron-specific enolase (NSE) levels are measured 48 hours after the cardiac arrest to assess the neuroprotective effects of the medication.

4 follow-up and evaluation

The primary outcome is evaluated at 48 hours post-arrest. Secondary outcomes include survival rates at 180 days and neurological function scores at hospital discharge and between 180 to 240 days after the cardiac arrest.

Who Can Join the Study?

The patient must be 18 years or older. If the exact age is not known, it is assumed to be 18 or older.
The patient must have experienced an out-of-hospital cardiac arrest (OHCA) that is believed to be caused by heart problems.
The patient must have had a primary shockable rhythm. This means the heart’s electrical activity was either ventricular fibrillation (a fast and irregular heartbeat) or pulseless ventricular tachycardia (a fast heartbeat without a pulse).
A decision must have been made to perform prehospital intubation after resuscitation. This means inserting a tube into the windpipe to help with breathing, as decided by the doctor treating the patient. Alternatively, the patient was intubated during CPR (cardiopulmonary resuscitation) and needs additional sedation.
It must be possible to give the study medicine injection before the patient arrives at the hospital.
The patient must have achieved ROSC (return of spontaneous circulation), meaning the heart has started beating on its own again, with a MAP (mean arterial pressure) of 40 mmHg or higher. This is a measure of blood pressure.

Who Cannot Join the Study?

Patients who have not experienced an out-of-hospital cardiac arrest. This means the heart stopped beating outside of a hospital setting.
Patients who are not within the specified age range for the study. The study may have specific age requirements.
Patients who belong to a group that is not included in the study. This could refer to certain health conditions or characteristics.
Patients who are not able to give consent or are considered part of a vulnerable population. This means individuals who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Ketamine is being studied for its potential to protect the brain after a person has been resuscitated from a cardiac arrest that happened outside of a hospital. It is used as part of the sedation process when the patient is intubated, which means a tube is placed into their airway to help them breathe.

Propofol is another medication used for sedation in this study. It is being compared to ketamine to see which one is better at protecting the brain after a cardiac arrest. Propofol helps keep the patient calm and comfortable during intubation.

Investigated diseases:

Cardiac arrest

Out-of-hospital cardiac arrest – This condition occurs when the heart suddenly stops beating effectively outside of a hospital setting, leading to a cessation of blood flow to the brain and other vital organs. It is often caused by an electrical malfunction in the heart, such as ventricular fibrillation or ventricular tachycardia. The immediate result is a loss of consciousness and absence of pulse, requiring urgent medical intervention. If untreated, it can lead to irreversible brain damage due to lack of oxygen. The progression of this condition depends on the speed and effectiveness of the resuscitation efforts. Rapid response with cardiopulmonary resuscitation (CPR) and defibrillation can improve outcomes significantly.

Trial ID:

2024-515987-29-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Esketamine Hydrochloride and Propofol for Patients After Cardiac Arrest

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?