A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Clinical Hospital Centre Zagreb
90 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria20
- 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.
Interventions
The patient will receive the intravenous opioid analgesic sufentanyl 0.2 mcg/kg over a period of 30 seconds. After 1 to 2 minutes the patient will receive remimazolam besylate intravenously in a dose of 5.0 mg over a period of 1 minute. After two minutes, a maintenance dose of 2.5 mg will be administered using the titration method over a period of 15 seconds until the desired sedation effect is achieved.The maximum intravenous dose of administered remimazolam besylate will be 33 mg.BIS monitoring and a modified MOAA/S scale will be used to assess the depth of sedation. The first measurement of the depth of sedation will be initially following the complete administration of the sedative remimazolam besylate and will serve as the initial/starting point. Afterwards, a measurement of the MOAA/S scale will be performed every 30 seconds for a total of 3 minutes. The most desirable level of sedation for the planned procedure is defined as a MOAA/S measurement of \<3.
The patient will be given intravenous opiod analgesia sufentanyl 0,2 mg/kg.within 30 seconds. After approximately 1-2 minutes the patient will receive the titrated anestetic propofol intravenously at a dose of 1,5 to 2,5 mg/kg (20,0 mg. propofol evry 10 seconds). In elderly patients and patients with ASA grade III, the total dose of propofol will be least 1 mg/kg with an administration rate of 10 every 10 seconds.
Locations(1)
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NCT07456111