A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Recruiting · NCT07456111 · Interventional (participants receive a specific treatment) · Lead sponsor: Clinical Hospital Centre Zagreb
View the official record on ClinicalTrials.gov →Interventions studied
PropofolRemimazolam besylate
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- UHC Zagreb - Zagreb, Croatia