Sedation with remimazolam versus propofol for colon polyp removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UHC Zagreb
  Zagreb, Croatia Recruiting

Study contacts

• Study coordinator: Željko Drvar, MD, PhD
• Email: zeljko.drvar@kbc-zagreb.hr
• Phone: 003851 2388 888

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.