RecruitingPhase 4NCT07456111

A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy

Sponsor

Clinical Hospital Centre Zagreb

Enrollment

90 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colonic Polyp Sedation Complication

Summary

The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures. Patients undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate/sufentanyl are circulatory and respiratory as or more stable when compared with propofol/sufentanyl sedation.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of sedation—remimazolam (a newer, short-acting sedative) and propofol (the most commonly used sedative)—in patients having a colonoscopy with polyp removal (polypectomy). The goal is to determine which drug offers better comfort, recovery, and safety during the procedure. **You may be eligible if...** - You are between 18 and 60 years old - You have one or more colon polyps confirmed by a previous colonoscopy and are scheduled for removal - Your procedure is expected to last 30–50 minutes - You have a healthy to mildly ill medical status (ASA classification I–III) - Your BMI is in the normal to overweight range (18.5–29.9) **You may NOT be eligible if...** - You are over 60 years old or have a BMI over 29.9 - You are considered very high surgical risk (ASA IV–V) - You have significant heart disease, lung disease, kidney disease, liver disease, or blood clotting disorders - You have a known allergy to soy, benzodiazepines, propofol, or opioids - You are pregnant, breastfeeding, or a child - You have a history of alcohol dependence or recreational drug use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemimazolam besylate

The patient will receive the intravenous opioid analgesic sufentanyl 0.2 mcg/kg over a period of 30 seconds. After 1 to 2 minutes the patient will receive remimazolam besylate intravenously in a dose of 5.0 mg over a period of 1 minute. After two minutes, a maintenance dose of 2.5 mg will be administered using the titration method over a period of 15 seconds until the desired sedation effect is achieved.The maximum intravenous dose of administered remimazolam besylate will be 33 mg.BIS monitoring and a modified MOAA/S scale will be used to assess the depth of sedation. The first measurement of the depth of sedation will be initially following the complete administration of the sedative remimazolam besylate and will serve as the initial/starting point. Afterwards, a measurement of the MOAA/S scale will be performed every 30 seconds for a total of 3 minutes. The most desirable level of sedation for the planned procedure is defined as a MOAA/S measurement of \<3.

DRUGPropofol

The patient will be given intravenous opiod analgesia sufentanyl 0,2 mg/kg.within 30 seconds. After approximately 1-2 minutes the patient will receive the titrated anestetic propofol intravenously at a dose of 1,5 to 2,5 mg/kg (20,0 mg. propofol evry 10 seconds). In elderly patients and patients with ASA grade III, the total dose of propofol will be least 1 mg/kg with an administration rate of 10 every 10 seconds.