Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Efficacy of Remimazolam with Fentanyl versus Midazolam with Fentanyl for sedation in screening colonoscopy: A randomized controlled study

This research study is looking at two common combinations of medicines used to help people feel calm and sleepy during a colonoscopy, which is a medical check of the bowel. One combination uses Remimazolam with Fentanyl, and the other uses Midazolam with Fentanyl. The main goal is to find out which of these combinations helps patients recover more quickly, meaning they can feel well enough to go home sooner after their colonoscopy. Researchers will also look at how comfortable patients are, if they need extra pain relief or sedatives, and how happy both the patients and the doctors are with the sedation. They'll also check how well patients can think after the procedure before they go home. This study aims to make colonoscopies more comfortable and recovery quicker for everyone.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Herlev Hospital

Enrolment target

200

Start

05 Apr 2023

Screening patients

What is this study about?

Imagine you're going for a colonoscopy, a routine check-up for your bowel. To make this procedure more comfortable for you, the doctor often gives you medicine to help you relax and feel sleepy. This study is like a careful comparison test between two different 'sleepy medicine' recipes. One recipe uses a medicine called Remimazolam mixed with another pain relievers called Fentanyl. The other recipe uses Midazolam, also mixed with Fentanyl. Both Remimazolam and Midazolam are sedatives, meaning they help you feel calm and less aware of what's happening during the procedure.

The main thing the researchers want to figure out is which of these two combinations helps you recover and feel ready to go home the fastest after your colonoscopy. They believe that a quicker recovery means less time spent in the hospital and a smoother experience overall for patients. By comparing these two common methods, doctors can learn how to make future colonoscopies even better and more patient-friendly.

Beyond just recovery time, the study will also look at other important details. For instance, they'll check if patients feel pain or discomfort during or after the procedure, if they need more medicine to stay calm or for pain, and how satisfied patients and doctors are with the treatment. They'll even check how well you can think and remember things before you leave. All this information helps doctors understand the full picture of how each sedation method works and which one might be best for people having a colonoscopy.

Key takeaways

This study compares two common sedation methods for colonoscopies.
It aims to find out which method helps patients recover faster and go home sooner.
You'll receive either Remimazolam/Fentanyl or Midazolam/Fentanyl for your procedure.
Researchers will also check your comfort, satisfaction, and mental clarity after sedation.
Participation involves close monitoring during your colonoscopy and recovery.
You have the right to stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 years or older, with no upper age limit, who are preparing to have a screening colonoscopy. A screening colonoscopy is a check-up done to look for changes in the bowel, often when you don't have specific symptoms, but rather as a preventative measure or due to family history.

Both men and women are welcome to take part in this research. The most important thing is that you are scheduled for a screening colonoscopy and fit others specific health criteria that the study team will discuss with you. They will review your medical history carefully to make sure the study is suitable and safe for you.

It's important to remember that for any clinical study, there are always some conditions that would prevent someone from joining. For example, if you have certain health conditions or are taking particular medications, you may not be able to participate. The study team will explain all the specific requirements in detail if you are interested.

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 a screening colonoscopy?
Are you comfortable with the possibility of receiving either of the two sedation options?
Do you understand that your medical history will be reviewed to ensure your safety for the study?
Do you want to contribute to research that could improve future colonoscopy experiences?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your experience will be very similar to what you would expect for a standard colonoscopy procedure, but with some extra observations. Before your procedure, you'll be assigned to receive one of the two sedation combinations (either Remimazolam with Fentanyl or Midazolam with Fentanyl). This choice is made by chance, like flipping a coin, so neither you nor your doctor can choose which one you get.

During your colonoscopy, the study team will carefully monitor how well the medication works and how you are feeling. After the procedure, they will keep track of how long it takes for you to recover and meet certain criteria that mean you are ready to go home. This includes checking your awareness, comfort, and feeling well enough. You might be asked to rate your pain and satisfaction, and they may also assess how well you can think before you are discharged.

The total participation time for this study will be focused around your colonoscopy appointment itself, including the preparation before the procedure, the procedure time, and the recovery period until you are ready to leave the hospital. There are no long-term follow-up visits or additional appointments required after your discharge from the hospital on the day of your colonoscopy.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to medical knowledge that could lead to improved sedation for future colonoscopies. You will receive standard care and close monitoring during your procedure. However, like with any medical procedure or medication, there are potential risks, side effects, or discomfort associated with the sedatives and pain relief medicines used. These will be fully explained to you by the study team before you consent to participate. It's very important to remember that your participation is completely voluntary, and you have the right 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
Denmark

Common questions

What is a colonoscopy?

A colonoscopy is a medical procedure where a doctor uses a thin, flexible tube with a camera to look inside your large bowel (colon) and rectum. It's used to check for changes like polyps or other issues.

What do the medicines do?

The medicines, Remimazolam or Midazolam, are sedatives that help you relax and feel sleepy during the colonoscopy. Fentanyl is a pain reliever that helps manage any discomfort.

Will I feel pain during the procedure?

The aim of the sedation and pain relief is to ensure you are comfortable and feel as little pain or discomfort as possible during the colonoscopy.

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

Your time in the hospital will cover your normal colonoscopy appointment, including the preparation, the procedure itself, and the recovery period until you are ready to go home. The study is specifically looking at how quickly you recover.

Is it safe to participate?

All medications used are standard for colonoscopy sedation. The research team will carefully monitor you throughout the process to ensure your safety and well-being. They will discuss all potential risks with you.