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

1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Academisch Ziekenhuis Leiden	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.07.2023

Trial locations

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.

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 ID:

2023-504229-37-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?