Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Esketamine and Remifentanil on Breathing in Healthy Volunteers

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of the medication Esketamine on the body's response to low oxygen levels, known as the hypoxic ventilatory response. The study involves healthy volunteers and aims to understand how Esketamine affects breathing when oxygen levels are low for a short period. Additionally, the study will explore how Esketamine can reverse the effects of another medication, Remifentanil, which can reduce the body's response to low oxygen.

Participants in the study will receive Esketamine and Remifentanil through an injection or infusion, which means the medication is delivered directly into the bloodstream. The study will also use a solution called normal saline, which is a simple saltwater solution, as part of the process. Another medication, Naloxone Hydrochloride, may be used to help understand the effects of the other drugs. The purpose of the study is to observe how these medications interact with the body's natural response to low oxygen levels.

The study will take place over a short period, with participants experiencing controlled low oxygen levels for specific durations. The researchers will monitor the participants' breathing and any side effects, such as changes in mood or perception, which are known as psychomimetic side effects. The study will also measure the levels of Esketamine in the blood to better understand its effects. This research aims to provide insights into how these medications can be used safely and effectively in medical settings.

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

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age between 18-45 years, a body mass index (BMI) between 19-30 kg/m², and the ability to read and understand the study information.

  2. Step 2

    Part 1: esketamine administration

    In the first part of the study, the effect of esketamine on the body's response to low oxygen levels will be tested. This involves a 25-minute period of reduced oxygen levels.

    During this phase, esketamine will be administered through an intravenous infusion. The dosage and frequency will be determined by the study team based on the study protocol.

  3. Step 3

    Part 2: remifentanil and esketamine administration

    In the second part, the study will examine how esketamine can reverse the effects of remifentanil, a medication that can reduce the body's response to low oxygen levels.

    This part involves two 7-minute periods of reduced oxygen levels, once with low carbon dioxide levels and once with high carbon dioxide levels.

    Remifentanil will be administered intravenously, followed by esketamine to observe the reversal effects.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the body's response to low oxygen levels will be closely monitored. This includes measuring the primary endpoint, which is the hypoxic ventilatory response.

    Secondary endpoints include observing any side effects and measuring esketamine levels in the blood.

  5. Step 5

    Completion of study

    After completing all parts of the study, a final evaluation will be conducted to ensure safety and gather all necessary data.

    Participants will be informed about the study's findings and any relevant information regarding their participation.

Who can join the trial?

5 criteria

  • Participants must be healthy volunteers.
  • Participants must be aged 18-45 years.
  • Participants must have a body mass index (BMI) between 19-30 kg/m2. BMI is a measure of body fat based on height and weight.
  • Participants must be able to read and understand the information provided about the study.
  • Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

  • Participants must be healthy volunteers. This means they should not have any ongoing medical conditions.
  • Participants must be within the specified age range. The exact age range is not provided here, but it is important to meet this requirement.
  • Both men and women can participate in the study.
  • Participants should not be part of a vulnerable population. This means they should not be in a group that might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Esketamine

    is a medication that is being studied for its effects on breathing when there is less oxygen available, a condition known as hypoxia. In this trial, researchers are looking at how esketamine affects the body's response to low oxygen levels over a period of time. They are also studying whether esketamine can help counteract the effects of another drug, remifentanil, which can reduce the body's natural response to low oxygen.

  • Remifentanil

    is a medication that is often used to relieve pain and is known to affect breathing. In this trial, remifentanil is used to see how it changes the body's response to low oxygen levels. The researchers are interested in understanding if esketamine can help reverse the effects of remifentanil on breathing when oxygen levels are low.

What is already known about the treatment

Esketamine – Esketamine is administered as a nasal spray, making it easy to use. It is currently being studied in clinical trials to understand its effects on breathing responses in healthy volunteers. The main therapeutic indication being explored is its potential to counteract breathing issues caused by other medications, like remifentanil. At the molecular level, esketamine works by blocking certain receptors in the brain, which can alter mood and perception. It is classified as a type of anesthetic and is also known for its rapid antidepressant effects.

Investigated diseases

Hypoxic Ventilatory Response – This is a physiological reaction of the body to low oxygen levels in the blood. When oxygen levels drop, the body increases breathing rate and depth to bring more oxygen into the lungs. This response helps maintain adequate oxygen supply to vital organs. The process involves sensors in the body detecting low oxygen and signaling the brain to adjust breathing. Over time, the body can adapt to sustained low oxygen levels, altering the response. This adaptation can vary based on individual health and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504229-37-00Estimated enrolment18 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.