Comparative Efficacy of Remimazolam and Propofol for Deep Sedation in Endoscopic Ultrasound Procedures in Patients with Gastric and Pancreatic Cancer

The primary objective of this study is to compare a remimazolam-based sedation regimen, managed by endoscopists, against a propofol-based sedation regimen administered by anesthesiologists during endoscopic ultrasound (EUS) procedures. This comparison aims to evaluate the efficacy and safety of these sedative agents in the context of gastrointestinal diagnostic and therapeutic interventions. Secondary objectives include the assessment of procedural time, the quality of sedation, and a cost-effectiveness analysis.

The sponsor did not provide information regarding the total number of participants. The study population consists of both male and female patients, aged between 18 and 64 years, who are scheduled for elective endoscopic ultrasound gastrointestinal procedures. Participants are required to undergo outpatient procedures and provide signed informed consent. The study involves patients with gastric and pancreatic cancer.

This randomized controlled trial is designed to compare a sedation regimen using remimazolam administered via intravenous infusion by endoscopists against a regimen using propofol administered by anesthesiologists. The study focuses on patients older than 18 years scheduled for elective endoscopic ultrasound (EUS) gastrointestinal procedures in an outpatient setting. The primary endpoint is a composite of cardiorespiratory adverse events, which includes oxygen desaturation, respiratory depression, hypotension, arrhythmia, tachycardia, bradycardia, and the necessity for anesthesiologist intervention. Secondary outcomes involve the assessment of sedation quality, awakening time, recovery room duration, and a cost-effectiveness analysis. The trial is estimated to occur between November 2025 and July 2026.

The experimental treatment consists of remimazolam, provided in the pharmaceutical form PHF00231MIG. This substance is administered via intravenous infusion at a dosage of 33 mg.

The comparator treatment involves propofol, utilizing the pharmaceutical form PHF742. Administration is conducted through intravenous infusion at a dosage of 6 mg/kg/h.

The efficacy of remimazolam compared to propofol will be assessed using a composite primary outcome consisting of cardiorespiratory adverse events. This composite endpoint includes oxygen desaturation, defined as SpO2 < 90% or the requirement to increase basal oxygen flow, and respiratory depression necessitating interventions such as chin-lift or bag-mask ventilation. Cardiovascular parameters evaluated include hypotension, characterized by a mean arterial pressure < 65 mmHg or a 20% decrease in systolic blood pressure from baseline, as well as arrhythmia. Heart rate fluctuations are monitored, specifically tachycardia (HR > 100 beats per minute or a 25% increase from baseline) or bradycardia (< 50 beats per minute). Additionally, the need for anesthesiologist intervention, as determined by the endoscopist, is included in the primary analysis.

Secondary endpoints involve the following measures:

• Quality of sedation as evaluated by patient and endoscopist perspectives.
• Procedural and recovery metrics, including time to start the procedure, awakening time, recovery room time, and hospital discharge time.
• Clinical requirements and complications, such as pain at injection, hospital admission, crossover to the alternative study arm, the need for tracheal intubation, and the use of additional hypnotic drugs.
• A cost-effectiveness analysis encompassing drug costs, personnel employment, endoscopy room occupancy, and recovery room occupancy.