What is this study testing for patients undergoing colonoscopic polypectomy?

This study is comparing two sedation methods, remimazolam besylate with sufentanyl and propofol with sufentanyl, to see how they affect circulatory and respiratory stability during colonoscopic polypectomy. Researchers aim to understand which sedation approach may better support patient safety and comfort during the procedure. The study is sponsored by Clinical Hospital Centre Zagreb.

Who may be eligible for this colonoscopic polypectomy clinical trial?

Adults aged 18 to 60 with one or more colonic polyps scheduled for colonoscopic polypectomy may be eligible. Both men and women can join if they have an ASA physical status of I to III and a BMI between 18.5 and 29.9. Patients with certain heart, lung, kidney, or liver conditions or allergies to study drugs are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this colonoscopic polypectomy clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs vary by participant and may not be covered. Participants should plan accordingly for any out-of-pocket expenses.

Actively Recruiting

Phase 4

Age: 18Years - 60Years

All Genders

ID07456111

Comparison of Remimazolam Besylate and Propofol Sedation During Colonoscopic Polypectomy Procedures

Led by Clinical Hospital Centre Zagreb · Updated on 2026-03-06

Participants Needed

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

Who Can Participate

Age: 18Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients of any gender aged 18 to 60 years
Confirmed diagnosis of one or more colonic polyps and scheduled for colonoscopy and polypectomy
Colonoscopy duration expected between 30 and 50 minutes
ASA physical status classification I to III
Body Mass Index between 18.5 and 29.9 kg/m2
Signed informed consent to participate in the study

You will not qualify if you...

Age over 60 years
ASA physical status classification IV or V
Body Mass Index greater than 29.9 kg/m2
High risk of vomiting, regurgitation, or aspiration of gastric contents
Uncontrolled hypertension with systolic pressure over 160 mmHg
Heart diseases including cardiomyopathy, rhythm disorders, low ejection fraction, valve issues, or coronary disease
Lung diseases such as pneumonia, COPD, asthma, or pulmonary tumors
Kidney failure or impaired kidney function (glomerular filtration rate 30-59 ml/min/1.73m2)
Liver diseases
Blood clotting or lymphatic tissue disorders
Advanced malignant disease
Allergies to soy, benzodiazepines, propofol, or opioids
Current use of analgesics or psycho-pharmaceutical medications
History of illicit drug use
Children, pregnant or nursing women
Alcohol dependency
Participation in other clinical studies
Refusal or failure to sign informed consent form

Research Team

Željko Drvar, MD, PhD

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