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Prehospital Sedation with Esketamine versus Propofol in Patients with Severe Acute Brain Injury

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

Patients with severe acute brain injury such as traumatic brain injury, subarachnoid haemorrhage or intracerebral haemorrhage often need to be sedated and have a breathing tube placed before they reach the hospital. In this study two medicines given through a vein are being compared: the test drug S-ketamine and the comparator drug propofol. Both are used to keep the patient calm, prevent pain and allow the tube to be placed safely.

The purpose of the study is to find out which medicine better prevents low blood pressure (hypotension) while the patient is being treated before hospital admission. Participants who need pre‑hospital sedation and ventilation are randomly given either the test drug or the comparator drug. Their blood pressure and oxygen levels are monitored from the first reading in the ambulance until they leave the trauma centre, and their recovery is checked again about six months later.

During the observation period the study records any episodes of very low or very high blood pressure, as well as low oxygen levels, and later evaluates how well patients can perform everyday activities using standard rating scales that measure functional ability. No additional procedures beyond the emergency care needed for the injury are performed as part of the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization to medication

    After enrollment, you will be randomly assigned to receive either propofol (the comparator) or esketamine (the test medication). the assignment is done by the study team and you will not know which medication is chosen.

  2. Step 2

    Prehospital medication administration

    The selected medication will be given through an intravenous (iv) line as a continuous infusion. the dose for propofol is 6 mg per kilogram of body weight per hour (6 mg/kg/h). the dose for esketamine is 4 mg per kilogram per hour (4 mg/kg/h). the infusion starts as soon as possible after randomization and continues until you leave the trauma centre.

  3. Step 3

    Intubation and mechanical ventilation

    You will be intubated, which means a tube will be placed in your airway to help you breathe. a ventilator will then provide breathing support while you are sedated.

  4. Step 4

    Continuous monitoring

    During the infusion, emergency personnel will continuously monitor your blood pressure and oxygen levels. the lowest average arterial pressure (map) recorded from the start of the medication until you leave the trauma centre is the primary measurement of the study.

  5. Step 5

    Transport to the trauma centre

    You will be transported to the trauma centre while the medication infusion continues. the infusion is maintained at the same dose until the final blood pressure measurement is taken at the trauma centre.

  6. Step 6

    End of intervention period

    Upon arrival at the trauma centre, the last blood pressure reading is recorded. after this measurement, the study medication infusion is stopped.

  7. Step 7

    Six‑month outcome assessment

    Six months after the randomization, you will be asked to complete two functional outcome questionnaires: the glucose outcome scale extended (gose), which rates recovery on a scale from 1 to 8, and the modified rankin scale (mrs), which rates disability on a scale from 1 to 6. these assessments are part of the study data collection.

Who can join the trial?

4 criteria

  • Age 18 years or older (if the exact age is not known, the person is assumed to be at least 18).
  • Presumed severe acute brain injury, which means a serious injury to the brain that happened suddenly, either from a trauma (like a blow to the head) or from a spontaneous event (such as bleeding inside the brain).
  • A medical decision to sedate (give medication to make the patient calm or sleep) and intubate (place a breathing tube into the airway) before reaching the hospital.
  • Expected to be taken directly from the scene (pre‑hospital setting) to a hospital that has a highly specialized intensive care unit for treating severe acute brain injury.

Who cannot join the trial?

3 criteria

  • If the doctor who treats you before you reach the hospital believes that using S‑ketamine or propofol would be unsafe for you (this is called the medicines being contraindicated), you cannot join the study.
  • If you have a known allergy to S‑ketamine or propofol (meaning your body reacts badly to the drug), you cannot join the study.
  • If you experienced an out‑of‑hospital cardiac arrest (OCHA), which means your heart stopped beating before you arrived at the hospital, you cannot join the study.
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Investigated drugs

  • Propofol

    is a medication given through an IV line that helps doctors quickly sedate patients. In this study, it is used as the standard treatment (the comparator) for people with severe acute brain injury who need to be sedated before they are taken to the hospital. The drug is delivered either as a quick injection (bolus) or as a continuous IV infusion, and it works by making the patient calm and unconscious so that they can be safely intubated and placed on a ventilator. The trial looks at how well propofol prevents low blood pressure (hypotension) during the pre‑hospital period.

  • S‑ketamine

    is an IV medication that also provides rapid sedation and pain relief. In this trial it is the new treatment being tested (the test drug) for patients with severe acute brain injury who need pre‑hospital sedation, intubation, and mechanical ventilation. Like propofol, it can be given as a quick IV bolus or as a continuous infusion. The study examines whether S‑ketamine is better at keeping blood pressure stable compared with propofol while still providing the needed sedation for safe airway management.

What is already known about the treatment

  • Propofol

    Propofol is given as an intravenous bolus or a continuous IV infusion, injected directly into a vein. It is a short‑acting anesthetic used for sedation, induction of anesthesia, and for patients who need to be intubated. It works by enhancing the activity of GABA receptors, which quiets brain activity and can lower blood pressure. Propofol is a well‑established drug in medical practice and is classified as a general intravenous anesthetic (ATC code N01AX10).

  • S‑ketamine

    S‑ketamine (esketamine hydrochloride) is administered by intravenous bolus or infusion, also injected directly into a vein. It is used for sedation, pain control, and to keep blood pressure stable in severe brain injury patients. It blocks NMDA receptors, reducing excitatory signals in the brain and helping maintain blood pressure. S‑ketamine is a newer but increasingly common medication, classified as an NMDA‑receptor antagonist (ATC code N01AX14).

Investigated diseases

  • Traumatic brain injury

    A traumatic brain injury occurs when an external force damages the brain tissue. It can cause bruising, bleeding, or swelling within the skull. Symptoms may evolve as swelling increases, leading to changes in consciousness or neurological function. The injury can progress over hours to days as inflammation and edema develop. Monitoring is needed to track changes in brain function.

  • Subarachnoid hemorrhage

    Subarachnoid hemorrhage is bleeding into the space between the brain and the thin tissues covering it. Blood in this space can irritate the brain surface and cause headaches and neck stiffness. As the bleeding spreads, it may lead to increased pressure on the brain. The condition can evolve as the blood is reabsorbed and as swelling changes. Ongoing observation is required to notice any worsening.

  • Intracerebral hemorrhage

    Intracerebral hemorrhage is bleeding directly into the brain tissue itself. The accumulation of blood creates a mass that can compress surrounding brain areas. Over time, the clot may expand, causing further swelling and changes in neurological status. The bleeding may gradually settle, but the surrounding tissue can be affected as edema develops. Continuous assessment helps to identify any progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525588-41-00Estimated enrolment284 patientsSponsorRegion Hovedstaden

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