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

RecruitingPhase 4Ages 18 Years - anyAllKoen Munters
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In plain words

What the trial is, and whether it could suit you

Rationale Midazolam is known for its safety, effectiveness for procedural sedation during gastrointestinal (GI) endoscopy and is used as standard sedative by endoscopists worldwide. Remimazolam is a novel, recently approved sedative, with the potential to facilitate a faster (neuropsychiatric) recovery. Therefore, it may potentially enable earlier discharge and improvement of post-procedural memory compared to midazolam. Furthermore, remimazolam may enhance patient satisfaction. Objective The investigators aim to compare the use of remimazolam and midazolam for sedation during diagnostic upper GI endoscopies in a randomized clinical trial. Main trial endpoints Time to full alertness (time interval from the last dosage midazolam or remimazolam to the first of 3 consecutive MOAA/S scores of 5). Secondary trial endpoints Interval between arrival in the recovery room and full alertness, p

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients age โ‰ฅ 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.
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What it tests

  • Remimazolam
  • Midazolam
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Where

3 sites
Gelre Hospitals
Apeldoorn, Netherlands
Rijnstate hospital
Arnhem, Netherlands
St Antonius hospital
Nieuwegein, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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