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

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, patient satisfaction (based on questionnaire after discharge and after 1 day), duration of amnesia (based on memory test after 1 day), time interval between last dosage of sedative and readiness for discharge (first Aldrete score of at least 9), total dosage and number of boluses for adequate sedation, time interval between first dosage of sedative and start of the procedure, endoscopist satisfaction (scored 0-10 after the procedure). Trial design Randomized, multicenter, double blind, clinical trial, which will take 2 days for study participants. Trial population Adult patients scheduled for…

This description comes directly from the study's public registry record.

Koen Munters, MD  ·  +31 088 755 07 21  ·  k.munters@antoniusziekenhuis.nl

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