REMIMAZOLAM for Gastric cancer|Pancreatic cancer

Inclusion criteria

• {"criterion_text":"-Patients >18 years"}
• {"criterion_text":"-Patients scheduled for elective EUS gastrointestinal procedures"}
• {"criterion_text":"-Signed informed consent"}
• {"criterion_text":"-Outpatient procedures"}

Exclusion criteria

• {"criterion_text":"-Patients < 18 years"}
• {"criterion_text":"-Patients scheduled for urgent EUS gastrointestinal procedures"}
• {"criterion_text":"-Known contraindications to the use of propofol and/or remimazolam"}
• {"criterion_text":"-Patient’s refusal to participate"}
• {"criterion_text":"-Procedures that require orotracheal intubation"}
• {"criterion_text":"-Pregnant and breastfeeding women"}
• {"criterion_text":"-Inpatient procedures"}

Primary endpoints

• {"endpoint_text":"-The primary outcome will be a composite outcome of cardiorespiratory adverse events","definition_or_measurement_approach":"Composite of the listed cardiorespiratory adverse events occurring during/after procedure (as defined by the individual primary endpoints below)."}
• {"endpoint_text":"-Oxygen desaturation, defined as SpO2 < 90% or need to increase the basal oxygen flow.","definition_or_measurement_approach":"Measured by pulse oximetry; event defined as SpO2 < 90% or requirement to increase baseline oxygen flow."}
• {"endpoint_text":"-Respiratory depression (desaturation requiring interventions as chin-stiff, bag mask ventilation)","definition_or_measurement_approach":"Defined as desaturation events requiring active airway interventions (chin lift/jaw thrust, bag-mask ventilation)."}
• {"endpoint_text":"-Hypotension (mean arterial pressure < 65 mmHg or 20% drop in systolic blood pressure from preprocedural values)","definition_or_measurement_approach":"Measured by blood pressure monitoring; event defined as MAP <65 mmHg or ≥20% drop in systolic BP from baseline."}
• {"endpoint_text":"-Arrhythmia","definition_or_measurement_approach":"Occurrence of cardiac arrhythmia documented during procedure (monitoring/ECG)."}
• {"endpoint_text":"-Tachycardia (HR > 100 beats for minute or a 25% increase from baseline HR) or bradycardia (<50 beats for minute)","definition_or_measurement_approach":"Measured by heart rate monitoring; tachycardia defined as HR >100 bpm or ≥25% increase from baseline; bradycardia defined as HR <50 bpm."}
• {"endpoint_text":"-Need for intervention of anesthesiologist (according to the evaluation of endoscopist).","definition_or_measurement_approach":"Recorded if anesthesiologist intervention was required as judged by the endoscopist."}

Secondary endpoints

• {"endpoint_text":"-Evaluation of the quality of sedation, through specific questions (according to patients ‘and endoscopist’s point of view)","definition_or_measurement_approach":"Assessment via specified patient and endoscopist questionnaires scoring sedation quality."}
• {"endpoint_text":"-Time needed to start the procedure","definition_or_measurement_approach":"Time interval from sedation start to procedure start, measured in minutes."}
• {"endpoint_text":"-Awakening time","definition_or_measurement_approach":"Time from end of sedation to patient awakening/recovery criteria met."}
• {"endpoint_text":"-Time spent in recovery room","definition_or_measurement_approach":"Duration of stay in recovery room, measured in minutes/hours."}
• {"endpoint_text":"-Time for hospital discharge","definition_or_measurement_approach":"Time from end of procedure to hospital discharge, measured in minutes/hours."}
• {"endpoint_text":"-Pain at injection","definition_or_measurement_approach":"Patient-reported pain at injection site using specified scale."}
• {"endpoint_text":"-Need for hospital admission","definition_or_measurement_approach":"Record of any post-procedural hospital admission."}
• {"endpoint_text":"-Need to crossover to other arm","definition_or_measurement_approach":"Documented instances where participant required crossover to alternate sedation arm."}
• {"endpoint_text":"-Need for advanced respiratory support (tracheal intubation)","definition_or_measurement_approach":"Documented requirement for tracheal intubation or advanced respiratory support."}
• {"endpoint_text":"-Need to use additional hypnotic drugs","definition_or_measurement_approach":"Record of additional hypnotic agents administered during procedure."}
• {"endpoint_text":"-A cost-effectiveness analysis will be also performed considering costs related to used drugs, employment of personnel and occupation time of endoscopy and recovery room. We will also record all the other drugs used during and after sedation, the time to wake up after sedation (endoscopy room occupancy time) and the time to hospital discharge (recovery room occupancy time).","definition_or_measurement_approach":"Health economic analysis using recorded drug costs, personnel employment, endoscopy and recovery room occupation times, and other drug use; outcomes include costs per procedure and resource utilization."}

Italy

Earliest CTIS Part Ii Submission Date

14-10-2025

Latest Decision Or Authorization Date

11-11-2025

Processing Time Days

28

Number Of Sites

1

Number Of Participants

332

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy