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A Study Comparing Remimazolam and Midazolam for Sedation in Adults During Upper Gastrointestinal Endoscopy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study compares two medications used for sedation during upper gastrointestinal endoscopy (a procedure to examine the upper digestive tract). The medications being studied are remimazolam (Byfavo) and midazolam, which are both sedative drugs given through an intravenous injection to help patients relax during the procedure.

The purpose of this research is to evaluate how long it takes patients to fully recover after receiving these sedative medications during their endoscopy procedure. During the study, participants will receive either remimazolam or midazolam as their sedation medication. After the procedure, medical staff will monitor how quickly patients return to being fully alert and ready to go home.

The medications will be given through a vein as either a single injection or continuous infusion. The maximum amount of medication that can be given is 100 mg for either drug over the course of one day. Throughout the procedure and recovery period, patients will be closely monitored for their response to the medication and any possible side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial sedation

    You will receive either midazolam or remimazolam through an intravenous injection (into your vein) to help you relax during the upper digestive tract examination.

    The medical team will monitor your alertness level throughout the procedure using a standardized scoring system.

  2. Step 2

    Endoscopy procedure

    A medical specialist will perform an examination of your upper digestive tract using an endoscope (a thin, flexible tube with a camera).

    Additional doses of sedative medication may be given if needed during the procedure.

  3. Step 3

    Recovery room monitoring

    After the procedure, you will be transferred to a recovery room where medical staff will monitor your recovery.

    Your alertness level will be checked regularly until you are fully awake.

    Medical staff will use a specific scoring system to determine when you are ready to go home.

  4. Step 4

    Post-procedure evaluation

    You will complete a satisfaction questionnaire about your experience.

    A simple memory test will be conducted to assess your recall of the procedure.

    Medical staff will document any side effects or unexpected reactions to the medication.

  5. Step 5

    Discharge assessment

    Before leaving, medical staff will ensure you meet all safety criteria for going home.

    You will receive instructions for post-procedure care and any necessary follow-up.

Who can join the trial?

5 criteria

  • You must be 18 years or older
  • You must be scheduled for a diagnostic upper GI endoscopy (a medical procedure where a doctor examines your upper digestive tract using a flexible tube with a camera) that requires procedural sedation (medication to help you relax and feel sleepy during the procedure)
  • You must be able to provide written consent and fully understand what participating in the trial involves
  • Both men and women can participate in this trial
  • You must be able to understand and comply with all study-related responsibilities

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years old
  • Known allergies or hypersensitivity to midazolam, remimazolam, or similar medications (hypersensitivity means having an unusual or extreme reaction to a substance)
  • History of difficult airway management
  • Pregnancy or breastfeeding
  • Sleep apnea (a condition where breathing repeatedly stops and starts during sleep)
  • Severe heart, lung, kidney, or liver disease
  • History of drug or alcohol abuse
  • Mental conditions that may affect the ability to provide informed consent
  • Taking medications that may interact with the study drugs
  • Body Mass Index (BMI) greater than 35 (a measure of body fat based on height and weight)
  • Participation in another clinical trial within the past 30 days
  • Inability to follow study instructions
  • Emergency or urgent endoscopy procedures
  • History of complications during previous endoscopic procedures
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Investigated drugs

  • Remimazolam

    is a short-acting sedative medication used to help patients relax during medical procedures. It belongs to the benzodiazepine class of drugs and helps reduce anxiety and provide sedation during endoscopic procedures. The medication works quickly and wears off faster than traditional sedatives.

  • Midazolam

    is a commonly used sedative medication that belongs to the benzodiazepine family. It helps patients feel calm and relaxed during medical procedures. This medication is widely used for sedation during endoscopic procedures and has been a standard choice for many years. It reduces anxiety and causes drowsiness, helping patients remain comfortable during the examination.

What is already known about the treatment

  • Remimazolam

    A fast-acting benzodiazepine sedative administered intravenously, primarily used for procedural sedation during medical procedures like endoscopy. This medication works by enhancing the effects of GABA neurotransmitters in the brain, leading to sedation and muscle relaxation, with the advantage of having a shorter recovery time compared to traditional sedatives. It belongs to the benzodiazepine class of drugs and is particularly valued in clinical settings for its rapid onset and quick clearance from the body.

  • Midazolam

    A widely used benzodiazepine medication administered intravenously or intramuscularly for procedural sedation and anesthesia induction, particularly common in endoscopic procedures. This medication acts on GABA receptors in the central nervous system to produce sedation, anxiety reduction, and muscle relaxation, while also causing temporary memory loss of the procedure. It belongs to the benzodiazepine class and is appreciated in clinical practice for its reliability and established safety profile, though it typically has a longer recovery time than newer alternatives.

Investigated diseases

Based on the provided data, this appears to be a study related to procedural sedation during endoscopic procedures, rather than specific diseases. However, I can describe the medical conditions that may be relevant to upper GI endoscopy: Gastroesophageal Reflux Disease (GERD) - A digestive disorder that occurs when stomach acid frequently flows back into the esophagus. It causes a burning sensation in the chest and can damage the lining of the esophagus over time. Gastritis - An inflammation of the stomach lining that can develop suddenly or gradually. The condition can cause stomach pain, nausea, and a feeling of fullness in the upper abdomen. Peptic Ulcer Disease - A condition where open sores develop on the inside lining of the stomach and the upper portion of the small intestine. Common symptoms include burning stomach pain, bloating, and feeling of fullness. Barrett's Esophagus - A condition in which the tissue lining the esophagus changes to tissue similar to the lining of the intestine. It develops in some people who have long-term GERD. Esophagitis - An inflammation of the esophagus that can cause difficulty swallowing, chest pain, and heartburn. The condition can result from various factors including acid reflux and infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516432-94-00Estimated enrolment148 patientsSponsorSint Antonius Ziekenhuis Stichting

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