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A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
RECRUITINGPhase 4Sponsored by Clinical Hospital Centre Zagreb
Actively Recruiting
PhasePhase 4
SponsorClinical Hospital Centre Zagreb
Started2025-01-01
Est. completion2027-11-30
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07456111
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
Age: 18 Years – 60 YearsHealthy volunteers accepted
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.
Conditions3
Colonic PolypDepressionSedation Complication
Interventions2
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Actively Recruiting
PhasePhase 4
SponsorClinical Hospital Centre Zagreb
Started2025-01-01
Est. completion2027-11-30
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07456111