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New sedative aims to make colonoscopy easier for IBD patients

NCT ID NCT07161297

Symptom relief Sponsor: Humanitas Clinical and Research Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether remimazolam, a newer sedative, works as well as or better than midazolam for colonoscopy in 200 adults with inflammatory bowel disease (Crohn's or colitis). Participants get one of the two drugs plus fentanyl for pain, then rate their satisfaction and are checked for how quickly they recover. The goal is to see if remimazolam leads to a better experience and faster discharge.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remimazolam (plus fentanyl)
What this could lead to
If remimazolam works better, it could make colonoscopy more comfortable and speed up recovery for people with IBD.
What could go wrong
This is a small, early-phase trial (200 people) comparing two sedatives, so it may not show a meaningful difference. Side effects like low oxygen levels are possible with any sedation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion Criteria * Age ≥18 years * Diagnosis of IBD (CD or UC) for ≥6 months * Scheduled colonoscopy for clinical or surveillance purposes * Ability to provide informed consent * Exclusion Criteria * ASA class IV * Allergy to benzodiazepines, opioids, flumazenil, or naloxone * Severe COPD * Obstructive sleep apnea * BMI \>35 * Pregnancy or lactation * Prior multiple ileocolonic resections or subtotal colectomy * Inability to complete questionnaires

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBD (inflammatory bowel disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Humanitas Research Hospital

    Rozzano, Milano, 20089, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.