IBD (Inflammatory Bowel Disease)Phase 4NCT07161297
Remimazolam for Colonoscopy in IBD Patients
A Phase 4 study testing Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. and Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. in people with IBD (Inflammatory Bowel Disease), run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. and Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of IBD (CD or UC) for ≥6 months
- Scheduled colonoscopy for clinical or surveillance purposes
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Armuzzi, MD PhD, +393392529254, alessandro.armuzzi@hunimed.eu
Cristina Bezzio, bezzioc@gmail.com
About this study
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
Read more
- Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?
- Does remimazolam allow faster recovery and discharge readiness compared to midazolam?
Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.
Participants will:
- Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy
- Complete a short questionnaire to rate their satisfaction after the procedure
- Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation., Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
- Keywords
- Inflammatory bowel disease (IBD), Remimazolam, Midazolam
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.Drug
- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.
Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.Drug
- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 (Remimazolam + Fentanyl) | Active comparator | ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy Receives: Drug: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. |
| Arm 1 (Midazolam + Fentanyl) | Active comparator | Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy. Receives: Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)
Measured: Immediately post-procedure
Secondary outcomes (5)
Patient high satisfaction
Proportion reporting "very satisfied" (Likert scale 1-4, 4 points)
Measured: Immediately post-procedure
Incidence of treatment-emergent adverse events
Proportion of patients experiencing any of the following adverse events (occurring after the administration of the study drug):
- Desaturation: peripheral oxygen saturation (SpO₂) below 90%
- Tachycardia: heart rate greater than 100 bpm
- Bradycardia: heart rate less than 50 bpm
- Hypotension: systolic blood pressure below 90 mmHg
Measured: Throughout the observation period (i.e., until discharge)
Discharge readiness 10'
Proportion of patients ready for discharge (PADSS ≥9)
Measured: 10 minutes post-procedure
Dischatge readiness 20'
Proportion of patients ready for discharge (PADSS ≥9)
Measured: 20 minutes post-procedure
Maximum net benefit
Proportion of patients reportinng "very satisfied" with sedation (Likert scale 1-4, 4 points) + ready for discharge (PADSS ≥9)
Measured: 10 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion7 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to sedation with either remimazolam or midazolam based on a pragmatic, time-based allocation schedule (i.e., all procedures during a given week used the same sedation regimen). This approach was chosen to ensure feasibility and avoid operator or patient selection bias. No individual-level randomization was performed.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161297
- Sponsor's protocol ID
- IBD-REMI 2223386_1
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes may be shared with qualified researchers upon reasonable request and subject to institutional and ethical approval. Data will be available after publication and will include demographic data, sedation details, outcome measures, and adverse events. Access will require a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam for Colonoscopy in IBD Patients
- ClinicalTrials.gov ID
- NCT07161297
- Acronym / sponsor ID
- IBD-REMI 2223386_1
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Inflammatory bowel disease (IBD), Remimazolam, Midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 7 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
- Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?
- Does remimazolam allow faster recovery and discharge readiness compared to midazolam?
Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.
Participants will:
- Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy
- Complete a short questionnaire to rate their satisfaction after the procedure
- Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to sedation with either remimazolam or midazolam based on a pragmatic, time-based allocation schedule (i.e., all procedures during a given week used the same sedation regimen). This approach was chosen to ensure feasibility and avoid operator or patient selection bias. No individual-level randomization was performed.
| Arm | Type | Receives |
|---|---|---|
| Arm 2 (Remimazolam + Fentanyl) | Active comparator | Drug: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy |
| Arm 1 (Midazolam + Fentanyl) | Active comparator | Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout. | Drug | Arm 2 (Remimazolam + Fentanyl) |
| Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout. | Drug | Arm 1 (Midazolam + Fentanyl) |
Primary outcome
Patient satisfaction
Time frame: Immediately post-procedure
Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)
5 secondary outcomes
Patient high satisfaction
Time frame: Immediately post-procedure
Incidence of treatment-emergent adverse events
Time frame: Throughout the observation period (i.e., until discharge)
Discharge readiness 10'
Time frame: 10 minutes post-procedure
Dischatge readiness 20'
Time frame: 20 minutes post-procedure
Maximum net benefit
Time frame: 10 minutes post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Requests should be submitted to: ibd@humanitas.it Subject: REMI-IBD IPDLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes may be shared with qualified researchers upon reasonable request and subject to institutional and ethical approval. Data will be available after publication and will include demographic data, sedation details, outcome measures, and adverse events. Access will require a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. and Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. in people with IBD (Inflammatory Bowel Disease), run by Humanitas Clinical and Research Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Alessandro Armuzzi, MD PhD (+393392529254, alessandro.armuzzi@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.