Search / Trial NCT06614036

Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial

Launched by KOEN MUNTERS · Sep 23, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Sedation Remimazolam Midazolam Gastroscopy Procedural Sedation

ClinConnect Summary

This clinical trial is comparing two sedatives, remimazolam and midazolam, to see which one helps patients recover faster after undergoing a diagnostic upper gastrointestinal (GI) endoscopy, a procedure used to look inside the stomach and intestines. Midazolam is commonly used and is known for being safe and effective. Remimazolam is a newer option that may allow for quicker recovery and better overall satisfaction for patients. The study will measure how long it takes for patients to feel alert after the procedure and how satisfied they are with their experience.

To participate in this trial, you need to be at least 18 years old and scheduled for a GI endoscopy that requires sedation. You won’t be able to join if you’re expected to receive certain pain medications or have other specific health issues. If you decide to participate, you'll be randomly assigned to receive either remimazolam or midazolam, and your vital signs and recovery will be monitored. After the procedure, you'll answer some questions about your memory and satisfaction to help researchers understand how each sedative impacts recovery. This study aims to improve patient care while keeping risks low, as both sedatives are already considered safe for use.

Gender

ALL

Eligibility 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.

About Koen Munters

Koen Munters is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes. With a commitment to innovation and excellence, the organization specializes in designing, conducting, and managing clinical trials across various therapeutic areas. Koen Munters emphasizes rigorous adherence to regulatory standards and ethical practices, ensuring that all studies are conducted with the utmost integrity and patient safety in mind. By fostering collaboration with healthcare professionals and leveraging cutting-edge methodologies, Koen Munters aims to contribute significantly to the development of new treatments and therapies that address unmet medical needs.

Locations

Nieuwegein, Utrecht, Netherlands

Arnhem, Gelderland, Netherlands

Apeldoorn, Gelderland, Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0