Not recruiting

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

Verified siteRegistered drug

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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

15 criteria

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

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Verified
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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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.

Remimazolam

What is already known about the treatment

Remimazolam
A fast-acting sedative medication administered through nasal spray using a Soft Mist device, belonging to the benzodiazepine class of drugs. This medication works by enhancing the effects of GABA neurotransmitters in the brain, producing sedation and reducing anxiety, with a notably rapid onset and shorter duration of action compared to traditional benzodiazepines. Currently being studied in clinical trials for intranasal administration, remimazolam shows promise in managing acute anxiety and stress conditions while offering a convenient and non-invasive delivery method.
Lidocaine
A local anesthetic medication used in this trial as a pre-treatment nasal spray to prevent irritation from the main treatment. It works by blocking sodium channels in nerve cells, temporarily numbing the nasal tissue and reducing discomfort during medication administration. Lidocaine has a well-established safety profile and is commonly used in various medical procedures for its rapid-acting local numbing effects, making it an ideal choice for improving patient comfort during intranasal drug delivery.

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.