AuthorisedTherapeutic use (Phase IV)Interventional

Remimazolam versus propofol for deep sedation during Endoscopic Ultrasound (EUS) procedures. A randomized controlled trial.

This research is looking at two different medicines, remimazolam and propofol, both used to help patients achieve a deep state of relaxation during a procedure called an Endoscopic Ultrasound (EUS). This scan is often used for conditions like stomach or pancreatic cancer. The main goal is to find out if one drug causes fewer problems with breathing or heart rate during the procedure. Researchers will also look at how quickly patients wake up, how long they need to stay in the recovery room, and how comfortable they feel. This study aims to help doctors understand which sedation option is best for patient safety and comfort during EUS.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

332

Start

11 Nov 2025

Gastric and pancreatic cancer

What is this study about?

This study is exploring which medicine works best to keep you deeply relaxed during a special internal examination called an Endoscopic Ultrasound (EUS). During an EUS, a thin, flexible tube with a camera and sound waves is guided into your body to get detailed pictures, often used when doctors are looking at conditions affecting the stomach or pancreas, such as cancer.

The two medicines being compared are called remimazolam and propofol. Both are used to provide 'deep sedation,' which means you'll be very sleepy and comfortable, and likely won't remember the procedure. The main thing the researchers want to find out is if one drug causes fewer problems with your heart and breathing while you're sedated. They will be carefully checking for things like your oxygen levels, blood pressure, and heart rate.

Besides safety, the study will also look at other important details. This includes how easily and quickly you wake up after the procedure, how long you need to stay in the recovery room, and how soon you can go home. They'll also consider how comfortable you felt, if you had any pain from the injection, and the overall cost-effectiveness of each drug. This information will help doctors choose the safest and most comfortable sedation method for patients undergoing EUS.

Key takeaways

This study compares two sedation drugs (remimazolam vs. propofol) for Endoscopic Ultrasound (EUS).
It aims to find which drug causes fewer breathing and heart problems during sedation.
Researchers will also look at how quickly you wake up and how long you need to recover.
Participation involves monitoring your health during your EUS and recovery.
The study helps improve patient safety and comfort for future EUS procedures.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. The study is open to both men and women.

The doctors will assess if you are suitable for the study based on your health and the specific needs of your Endoscopic Ultrasound procedure. This ensures that the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for an Endoscopic Ultrasound (EUS) procedure?
Are you generally well enough to receive deep sedation?
Are you able to provide your consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a detailed discussion with the study team to make sure it's right for you. If you qualify, you will receive either remimazolam or propofol to help you relax during your Endoscopic Ultrasound (EUS) procedure. The specific drug you receive will be chosen by chance, like flipping a coin.

During and immediately after your EUS, the study team will closely monitor your heart rate, breathing, oxygen levels, and blood pressure. They'll also record how quickly you wake up and how long you stay in the recovery room before you are ready to go home. You won't need extra visits beyond your normal EUS appointment and recovery time, but the team will carefully collect information during your hospital stay.

Potential risks and benefits

Taking part in this study may offer a direct benefit to you by ensuring very close monitoring of your health during deep sedation, which could help identify and manage any side effects quickly. It also helps future patients by improving our understanding of the best and safest sedation practices. However, like any medical procedure involving sedation, there are potential risks, such as temporary changes in breathing, blood pressure, or heart rate. The study team will be ready to manage these if they occur. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is an Endoscopic Ultrasound (EUS)?

It's a medical procedure where doctors use a special tube with a camera and ultrasound to look closely at organs like your stomach or pancreas.

Why am I being sedated?

Sedation helps you feel relaxed, comfortable, and often unaware of what's happening during the EUS procedure.

What do 'remimazolam' and 'propofol' do?

These are both medicines used to help you achieve a deep state of relaxation or sleep during your procedure.

Will I know which drug I received?

No, the doctors will randomly assign you to one drug or the other, and neither you nor your doctor will know which one you received during the study to keep things fair.

How long will I be in the hospital for the study?

The study aims to measure your recovery time, so you’ll be in the hospital for your EUS procedure and the necessary recovery period afterward, just like a standard procedure.