Comparing remimazolam and midazolam for sedation during upper GI endoscopy
Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial
PHASE4 · St. Antonius Hospital · NCT06614036
This study tests whether a new sedative called remimazolam helps people recover faster and feel better after an upper GI endoscopy compared to the standard sedative, midazolam.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital (other) |
| Locations | 3 sites (Apeldoorn, Gelderland and 2 other locations) |
| Trial ID | NCT06614036 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of remimazolam and midazolam as sedatives during diagnostic upper gastrointestinal endoscopies. The study will randomly assign participants to receive either sedative and measure key outcomes such as time to full alertness and patient satisfaction. By evaluating these parameters, the trial seeks to determine if remimazolam can provide a faster recovery and improved post-procedural memory compared to the standard sedative, midazolam.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who are scheduled for a diagnostic upper GI endoscopy requiring procedural sedation.
Not a fit: Patients who are anticipated to require opioids during the procedure or have a high ASA score (4) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices, allowing for quicker recovery times and enhanced patient satisfaction during and after endoscopic procedures.
How similar studies have performed: Previous studies have shown promising results with remimazolam, indicating its potential advantages over traditional sedatives like midazolam, making this approach both relevant and timely.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age ≥ 18 years. * Scheduled for a diagnostic upper GI endoscopy with procedural sedation. * Ability to provide written informed consent, and to understand the responsibilities of trial participation. Exclusion Criteria: * Anticipated use of opioids, such as a therapeutic endoscopy or any other reason. * ASA score of 4. * Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent.
Where this trial is running
Apeldoorn, Gelderland and 2 other locations
- Gelre Hospitals — Apeldoorn, Gelderland, Netherlands (RECRUITING)
- Rijnstate hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
- St Antonius hospital — Nieuwegein, Utrecht, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Koen Munters, MD
- Email: k.munters@antoniusziekenhuis.nl
- Phone: +31 088 755 07 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sedation for Diagnostic Gastroscopy, sedation, remimazolam, midazolam, gastroscopy, procedural sedation