Tolerability of Remimazolam Versus Midazolam in EUS
ConditionSedation During GI Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Socio Sanitaria Territoriale di Lecco
About this trial
This study will observe and compare patient experience during outpatient diagnostic endoscopic ultrasound (EUS) when moderate sedation is provided with either remimazolam plus fentanyl or midazolam plus fentanyl, according to routine clinical practice.
Both sedation approaches are currently used in standard care. The choice of sedative will be made by the treating physician as part of usual practice and not assigned by the study. The purpose of the study is to evaluate how patients tolerate the procedure with each sedation strategy, focusing on comfort, recovery, and overall procedural experience.
After the procedure, participants will be asked to complete questionnaires about their experience at 1 hour and 24 hours after EUS. The study will also collect information on sedation effectiveness, operator satisfaction, recovery time, adverse events, and costs.
This is a prospective observational single-center study involving adult outpatients undergoing diagnostic EUS. Information collected during routine care, including vital signs, recovery measures, and procedural data, will be analyzed to compare outcomes between the two sedation approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Outpatients undergoing diagnostic EUS (upper GI or biliopancreatic)
Informed consent obtained
Disqualifiers
Known allergy to study medications
Recent upper respiratory infection or asthma attack
History of sedative or opioid addiction
Advanced oncologic disease with peritoneal metastases
Trial population
Adult outpatients undergoing diagnostic EUS
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
126 Participants
are grouped into 2 trial groupsGroup A: Remimazolam
Group B: Midazolam
Trial outcomes
Primary outcomes
1
Tolerability of sedation
Evaluated using patient-reported scale for tolerability of endoscopic procedures (PRO-STEP scale). The scale consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and throat pain. All questions are scored on a Likert scale from 0 to 10. Thus, higher scores underly a worse procedural tolerability.
Time frame
Tolerability of sedation will be evaluated 1 hour and 24 hours after the end of the endoscopic procedureSecondary outcomes
1
operator's satisfaction
Numeric Rating Scale (NRS), ranging from 0 (lowest satisfaction) to 10 (highest satisfaction).
Time frame
Periprocedural: Immediately after the endoscopic procedure2
recovery time
evaluated using Modified Aldrete (M-Aldrete) score, which evaluates a patient's recovery after anesthesia by assessing activity, respiration, circulation, consciousness, and oxygen saturation. It ranges from 0 to 10 and is used in the post-anesthesia care unit (PACU) to determine readiness for discharge (typically ≥9).
Time frame
Perioperative/Periprocedural: up to 2 hours after the procedureSponsors and contacts
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Source ClinicalTrials.gov