Title: Evaluation of nasal remimazolam and lidocaine for sedation and anxiety in adults: Testing comfort and effectiveness of nasal spray delivery

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What is this study about?

This study examines the effects of remimazolam, a medication used for sedation, in people with stress and anxiety. The purpose is to evaluate how well this medicine works and how comfortable it is when given as a nasal spray.

The treatment involves using a special nasal spray device to deliver two doses of remimazolam. Before giving remimazolam, participants will receive lidocaine (a numbing medicine) through the same type of nasal spray to prevent discomfort in the nose. The total amount of remimazolam used will be 40 milligrams, given as two separate 20-milligram doses.

During the study, medical staff will monitor how sleepy participants become and how they feel after receiving the medication. They will track these effects for several hours after the medication is given. This will help determine if giving remimazolam as a nasal spray could be an effective way to provide sedation.

1 Initial preparation

A medical professional will check your baseline measurements, including the Bispectral Index (BIS) value, which measures brain activity.

You will complete several self-assessment surveys about your alertness and relaxation levels using a scale from 0 to 100.

2 Local anesthetic administration

You will receive 20 mg of lidocaine through a nasal spray device to prevent discomfort in your nasal passage.

This medication will numb your nasal cavity before the main medication is administered.

3 Main medication administration

You will receive two doses of 20 mg remimazolam (total 40 mg) through a special nasal spray device.

The medication is designed to have a calming effect.

4 Monitoring period

Medical staff will monitor your brain activity and sedation levels for 3 hours (180 minutes).

Your alertness and comfort levels will be checked at specific intervals: 5, 10, 15, 20, 30, 40, 50, 60, 90, and 180 minutes after receiving the medication.

You will complete the same self-assessment surveys about alertness and relaxation at these time points.

5 Final assessment

After 3 hours, medical staff will perform final measurements of your brain activity and sedation levels.

You will complete final self-assessment surveys about your experience.

Who Can Join the Study?

  • You must be between 18 and 60 years old
  • Your lean body weight (weight without fat tissue) must be at least 50 kilograms
  • You must be in ASA physical status class I (this means you are a healthy person with no medical conditions, do not smoke, and have only minimal alcohol use)
  • Both men and women can participate in this study
  • You must not be part of a vulnerable population (such as pregnant women, prisoners, or persons unable to give consent)
  • You must be experiencing stress or anxiety symptoms

Who Cannot Join the Study?

  • Age below 18 or above 65 years
  • Known allergies or hypersensitivity to remimazolam, lidocaine, or similar medications
  • Current pregnancy or breastfeeding
  • History of nasal conditions (such as frequent nosebleeds, deviated septum, or chronic sinusitis)
  • Significant respiratory problems (breathing difficulties)
  • Uncontrolled high blood pressure
  • Severe heart conditions
  • Current use of medications that might interact with the study drug
  • History of substance abuse or addiction
  • Mental health conditions that could affect the ability to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Body weight less than 50 kg (110 pounds) or more than 100 kg (220 pounds)
  • Abnormal liver or kidney function
  • Sleep apnea (temporary pauses in breathing during sleep)
  • History of adverse reactions to sedative medications

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.12.2024

Trial locations

Investigated drugs:

Remimazolam is a sedative medication that in this trial is given through the nose using a special nasal spray device. It helps to make patients calm and sleepy. This medication belongs to the same family of drugs as midazolam, which is commonly used for sedation.

Lidocaine is a local anesthetic medication that numbs the area where it’s applied. In this trial, it’s sprayed into the nose before remimazolam to prevent discomfort and irritation of the nasal passages. It helps make the administration of remimazolam more comfortable for patients.

Investigated diseases:

Anxiety – A mental health condition characterized by persistent feelings of worry, fear, and unease. Anxiety can manifest through both psychological and physical symptoms, including racing thoughts, restlessness, difficulty concentrating, and increased heart rate. The condition can vary in intensity from mild to severe, affecting daily activities and social interactions. Physical symptoms may include muscle tension, sweating, and shortness of breath.

Stress – A natural physical and mental response to life experiences that causes emotional or physical tension. Stress typically triggers the body’s “fight-or-flight” response, leading to various physiological changes including increased heart rate and elevated blood pressure. It can affect sleep patterns, appetite, and energy levels. The condition can be acute (short-term) or chronic (long-lasting), impacting both mental and physical well-being.

Trial ID:
2024-516493-30-01
Trial Phase:
Therapeutic exploratory (Phase II)

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