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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 (Remimazolam + Fentanyl) | Active Comparator | ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy |
|
| Arm 1 (Midazolam + Fentanyl) | Active Comparator | Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points) | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient high satisfaction | Proportion reporting "very satisfied" (Likert scale 1-4, 4 points) | 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):
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopy metrics - cecal intubation rate | Percentage of procedures where the endoscope successfully reaches the cecum and can be visually confirmed by inspecting the appendiceal orifice | During procedure |
| Endoscopy metrics - cecal intubation time |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Alessandro Armuzzi, MD PhD | Contact | +393392529254 | alessandro.armuzzi@hunimed.eu | |
| Cristina Bezzio | Contact | +393392529254 | bezzioc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Milano | 20089 | Italy |
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| Label | URL |
|---|---|
| Requests should be submitted to: ibd@humanitas.it Subject: REMI-IBD IPD | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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.
IPD will be made available within 6 months after publication of the main results and will remain available for up to 1 year thereafter.
Qualified researchers affiliated with academic institutions, healthcare organizations, or regulatory agencies will be able to request access to the de-identified individual participant data (IPD), including demographic variables, treatment allocation, sedation response, recovery scores, adverse events, and primary/secondary outcomes. Supporting documents such as the study protocol and statistical analysis plan (SAP) will also be available.
Access will be granted upon submission and approval of a written data request, which must include a brief research proposal and data use rationale. A data-sharing agreement must be signed prior to access. Data will be shared securely via encrypted files or institutional data-sharing platforms approved by the sponsor institution.
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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.
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|
| 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. |
|
| Throughout the observation period (i.e., until discharge) |
| Discharge readiness 10' | Proportion of patients ready for discharge (PADSS ≥9) | 10 minutes post-procedure |
| Dischatge readiness 20' | Proportion of patients ready for discharge (PADSS ≥9) | 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) | 10 minutes post-procedure |
Time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base
| During procedure |
Requests should be submitted to: ibd@humanitas.it Subject: REMI-IBD |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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