A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Recruiting
Phase 4Interventional Study
Colonic PolypSedation Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Clinical Hospital Centre Zagreb · Other
Who this trial is looking for
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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.
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Eligibility 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 …
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.
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