Status:
RECRUITING
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Lead Sponsor:
Clinical Hospital Centre Zagreb
Conditions:
Colonic Polyp
Sedation Complication
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 unde...
Detailed Description
Following the approval for the research by the Ethics Committee (Clinical Hospital Center, Zagreb, Croatia), a total of ninety (90) patients will be included in the research. Forty five (45) patients ...
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 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07456111
Start Date
January 1 2025
End Date
December 30 2028
Last Update
March 6 2026
Active Locations (1)
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1
UHC Zagreb
Zagreb, Croatia, 10000