IBD (Inflammatory Bowel Disease)
Conditions
Keywords
Inflammatory bowel disease (IBD), Remimazolam, Midazolam
Brief 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. 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
Interventions
DRUGIntravenous 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.
DRUGIntravenous 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.
Sponsors
Humanitas Clinical and Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Immediately post-procedure | Proportion of patients reporting at least satisfied with sedation (Likert scale 1-4, 3 or 4 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dischatge readiness 20' | 20 minutes post-procedure | Proportion of patients ready for discharge (PADSS ≥9) |
| Patient high satisfaction | Immediately post-procedure | Proportion reporting very satisfied (Likert scale 1-4, 4 points) |
| Incidence of treatment-emergent adverse events | Throughout the observation period (i.e., until discharge) | 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 |
| Discharge readiness 10' | 10 minutes post-procedure | Proportion of patients ready for discharge (PADSS ≥9) |
| Maximum net benefit | 10 minutes post-procedure | Proportion of patients reportinng very satisfied with sedation (Likert scale 1-4, 4 points) + ready for discharge (PADSS ≥9) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endoscopy metrics - cecal intubation rate | During procedure | Percentage of procedures where the endoscope successfully reaches the cecum and can be visually confirmed by inspecting the appendiceal orifice |
| Endoscopy metrics - cecal intubation time | During procedure | Time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base |
Countries
Italy
Contacts
Primary ContactCristina Alessandro Armuzzi, MD PhD
Backup ContactCristina Bezzio
Outcome results
None listed