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

Recruiting now · Phase 4

Conditions studied: Colonic Polyp, Sedation Complication

In brief

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.

Key facts

Study ID

NCT07456111

Run by

Clinical Hospital Centre Zagreb

People needed

90

Starts

2025-01-01

Expected to finish

2028-12-30

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients both male and female
• ages 18 to 60 years,
• with one or more colonic polyps confirmed by colonoscopy and scheduled for a colonoscopy and polypectomy
• The duration of the colonoscopy ranges from 30 to 50 minutes.
• ASA status (American Society of Anaesthesiologists physical status) I-III.
• BMI (Body mass index) 18.5-29.9 kg/m2.
• Only patients who signed an informed consent waiver and consented to participate in the research study.

You may not qualify if…

• Patients aged >60 years
• ASA status IV-V,
• BMI >29.9 kg/m2,
• a high risk of vomiting, regurgitation and/or aspiration of gastric contents.
• Patients with:
• uncontrolled hypertension (systolic pressure >160 mmHg),
• heart disease (cardiomyopathy, cardiac-rhythm disorder, left ventricular ejection fraction <45%, stenosis or heart valve insufficiency and coronary heart disease)
• lung disease (pneumonia, chronic obstructive pulmonary disease, asthma and pulmonary tumors),
• kidney diseases (kidney failure, GF 30/59 ml/min/1.73m2),
• liver diseases,
• coagulation disorders
• lymphatic tissue diseases
• extended malignant disease.
• History of allergy on nutritional allergens including soy bean, benzodiazepines, propofol or opioids.
• Patients who currently use analgesic medications or other psycho-pharmaceuticals.
• History of illicit drug use.
• Children, pregnant and nursing women.
• Alcohol dependency.
• Patients involved in other clinical research studies,
• patients who refused to take part in the research or have not signed the written informed consent form.

Where it is running

• UHC Zagreb — Zagreb, Croatia (enrolling)

Full record on ClinicalTrials.gov

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