Actively Recruiting
Comparing Remimazolam Besylate and Propofol Sedation for Adults Aged 18 to 60 Undergoing Colonoscopic Polypectomy
Led by Clinical Hospital Centre Zagreb · Updated on 2026-03-06
90
Participants Needed
1
Research Sites
56 weeks
Total Duration
AI-Summary
What this Trial Is About
This clinical trial is investigating sedation methods during colonoscopic polypectomy procedures. It aims to compare the effects of remimazolam besylate combined with sufentanyl versus propofol combined with sufentanyl on circulatory and respiratory stability. The study also evaluates the incidence of hypotension and respiratory depression, as well as the overall sedation success and recovery times in adult patients. Participants are randomly assigned to one of two groups a study group receiving remimazolam besylate and sufentanyl, and a control group receiving propofol and sufentanyl. In both groups, patients receive intravenous sufentanyl followed by the sedative drug, with doses tailored to achieve the desired sedation level assessed by BIS monitoring and the Modified Observers Assessment of Alertness and Sedation Scale MOAAS. Continuous oxygen flow and non-invasive monitoring are applied during the procedure. Throughout the study, patients are monitored for vital signs including oxygen saturation, heart rate, blood pressure, and respiratory rate before, during, and after the procedure. Sedation depth, time to adequate sedation, full alertness, and recovery readiness are measured. Researchers also track drug doses, procedure duration, infusion volumes, and post-procedure symptoms such as pain, nausea, and vomiting. The total observation period per participant spans approximately 2 to 4 hours.
CONDITIONS
Brief Title
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Research Team
Ž
Željko Drvar, MD, PhD
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