Sedation with remimazolam versus propofol for colon polyp removal
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
This test checks whether remimazolam besylate plus sufentanyl gives more stable blood pressure and breathing than propofol plus sufentanyl for adults 18–60 having colonoscopic polypectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07456111 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled comparison enrolling 90 adults undergoing colonoscopic polypectomy, with 45 patients assigned to remimazolam besylate plus sufentanyl and 45 to propofol plus sufentanyl. The primary focus is on circulatory and respiratory stability during procedural sedation, specifically the incidence of hypotension and respiratory depression. Secondary measures include sedation success and timing outcomes such as time to adequate sedation, time to full consciousness, and time to complete recovery. All procedures are performed at the Clinical Hospital Centre Zagreb with standard IV access and monitoring.
Who should consider this trial
Good fit: Adults aged 18–60 with one or more colonic polyps scheduled for colonoscopic polypectomy, ASA I–III, BMI 18.5–29.9 kg/m2, who provide informed consent are the intended participants.
Not a fit: Patients over 60, with BMI >29.9, ASA IV–V, significant cardiac, pulmonary, or renal disease, high aspiration risk, or other exclusion criteria are unlikely to receive benefit from these results.
Why it matters
Potential benefit: If successful, this approach could reduce episodes of low blood pressure and breathing problems during polypectomy and speed safer recovery.
How similar studies have performed: Prior procedural sedation studies suggest remimazolam often causes less hemodynamic and respiratory depression than propofol, but direct head-to-head data specifically for polypectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Zagreb
- UHC Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Željko Drvar, MD, PhD
- Email: zeljko.drvar@kbc-zagreb.hr
- Phone: 003851 2388 888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.