Actively Recruiting
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Led by Clinical Hospital Centre Zagreb · Updated on 2026-03-06
90
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients male or female
- Aged 18 to 60 years
- Have one or more colonic polyps confirmed by colonoscopy and scheduled for colonoscopy and polypectomy
- Colonoscopy duration between 30 to 50 minutes
- ASA physical status 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...
- Older than 60 years
- ASA physical status IV or V
- Body mass index greater than 29.9 kg/m2
- High risk of vomiting, regurgitation, or aspiration of stomach contents
- Uncontrolled hypertension with systolic pressure over 160 mmHg
- Heart diseases including cardiomyopathy, cardiac rhythm disorders, left ventricular ejection fraction below 45%, valve problems, or coronary heart disease
- Lung diseases such as pneumonia, COPD, asthma, or lung tumors
- Kidney diseases including failure or low glomerular filtration rate
- Liver diseases
- Blood clotting disorders
- Lymphatic tissue diseases
- Advanced cancer
- Allergies to soy, benzodiazepines, propofol, or opioids
- Current use of painkillers or psychiatric medications
- History of illicit drug use
- Children, pregnant, or breastfeeding women
- Alcohol dependency
- Participation in other clinical research
- Refusal to participate or not signing consent form
AI-Screening
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Trial Site Locations
Total: 1 location
1
UHC Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
Research Team
Ž
Željko Drvar, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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