SYF540d823de5f948a6b30f17b0a2a31335Registry ID: 2025-521784-12-00|RecruitingPhase 4
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interventional
N/A
1 country
1
To compare a remimazolam-based sedation regimen managed by endoscopists to a propofol-based sedation regimen performed by anesthesiologists during EUS gastrointestinal procedures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2025
Actual (reported)The primary outcome will be a composite outcome of cardiorespiratory adverse events
Oxygen desaturation, defined as SpO2 < 90% or need to increase the basal oxygen flow.
Respiratory depression (desaturation requiring interventions as chin-stiff, bag mask ventilation)
Hypotension (mean arterial pressure < 65 mmHg or 20% drop in systolic blood pressure from preprocedural values)
Arrhythmia
Tachycardia (HR > 100 beats for minute or a 25% increase from baseline HR) or bradycardia (<50 beats for minute)
Need for intervention of anesthesiologist (according to the evaluation of endoscopist).
Evaluation of the quality of sedation, through specific questions (according to patients ‘and endoscopist’s point of view)
Time needed to start the procedure
Awakening time
Time spent in recovery room
Time for hospital discharge
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Stefano Turi
First Submitted
July 25, 2025
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